Devices › Catheter, hemodialysis, non-implanted
Device brand name · Catheter hemodialysis non-implanted
Mahurkar: medical device reports filed with FDA
1,046 reports name it, 2008–2025. Manufacturer given most often on reports: Covidien Mfg Solutions. Product code MPB.
- 1,046
- device reports naming the brand
- 0% of all MAUDE reports · about 57 a year
- 6
- reports, 12 months to August 2026
- 125 in the 12 months before
- 92.4%
- classified as malfunction
- 75.8% across the product code
- 1.1%
- classified as death, as reported
- 11 reports · not verified by FDA
1,046 medical device reports received by FDA name the brand "Mahurkar" (catheter hemodialysis non-implanted); the manufacturer given most often on reports is Covidien Mfg Solutions; received from March 2008 to November 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
6 reports arrived in the 12 months to August 2026, down 95% from 125 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (92.4%), injury (6.6%) and death (1.1%); across all catheter, hemodialysis, non-implanted reports (product code MPB) death is recorded in 2.3% and malfunction in 75.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material puncture/hole (25%), break (17.2%) and difficult to remove (15.1%). The patient problems coded most often are no patient involvement, foreign body in patient and unintended radiation exposure. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,212 reports carrying product code MPB. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Material puncture/hole | 262 | 25% | 5.9% |
| Breakthe device broke | 180 | 17.2% | 7.1% |
| Difficult to removethe device was hard to remove | 158 | 15.1% | 4.1% |
| Product quality problem | 117 | 11.2% | 2.6% |
| Obstruction of flow | 93 | 8.9% | 1.1% |
| Infusion or flow problema problem with flow or infusion | 56 | 5.4% | 0.5% |
| Unraveled material | 51 | 4.9% | 3.8% |
| Insufficient flow or under infusion | 42 | 4% | 0.3% |
| Fluid/blood leak | 38 | 3.6% | 5.2% |
| Material integrity problema problem with the device material | 38 | 3.6% | 0.6% |
| Occlusion within devicethe device blocked | 36 | 3.4% | 0.1% |
| Detachment of device or device componentpart of the device came off | 33 | 3.2% | 1.2% |
| Difficult to advance | 27 | 2.6% | 0.3% |
| Material frayed | 24 | 2.3% | 3.1% |
| Insufficient device problem information | 23 | 2.2% | 0.2% |
| Material deformation | 18 | 1.7% | 4.7% |
| Migration or expulsion of device | 18 | 1.7% | 1.6% |
| Material fragmentation | 16 | 1.5% | 0.2% |
| Defective component | 14 | 1.3% | 0.7% |
| Migrationthe device moved from where it was placed | 14 | 1.3% | 0.6% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 33 | 3.2% |
| Foreign body in patientpart of a device left in the patient | 13 | 1.2% |
| Unintended radiation exposure | 13 | 1.2% |
| Blood loss | 11 | 1.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 10 | 1% |
| Hemorrhage/blood loss/bleeding | 10 | 1% |
| Radiation exposure, unintended | 9 | 0.9% |
| Deaththe patient died; cause not stated by this term | 8 | 0.8% |
| Hematomaa collection of blood under the skin or in tissue | 7 | 0.7% |
| Inflammationinflammation | 5 | 0.5% |
| Fever | 4 | 0.4% |
| Painpain, site not specified | 4 | 0.4% |
| Skin discoloration | 4 | 0.4% |
| Perforation of vessels | 3 | 0.3% |
| Air embolism | 2 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Mahurkar | Product code MPB | All MAUDE reports |
|---|---|---|---|
| Reports | 1,046 | 3,212 | 26,136,888 |
| Share of that pool | — | 32.6% | 0% |
| Classified as death, per 1,000 reports | 11 | 23 | 9 |
| Classified as injury | 6.6% | 18.9% | 36.2% |
| Classified as malfunction | 92.4% | 75.8% | 62.3% |
| Filed by the manufacturer | 98.6% | 93.8% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code MPB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Arrow Hemodialysis Set 2-Lumen 12 Fr X 20 Cm | 404 | 68 | 0.2% |
| Arrow Hemodialysis Set 2-Lumen 12 Fr X 16 Cm | 198 | 26 | 1% |
| Mahurkar Elite | 152 | 10 | 3.3% |
| Ash Split Catheter | 258 | 0 | 3.5% |
| Dialysis Unknown | 402 | 6 | 5% |
| Kendall | 213 | 23 | 2.3% |
| Arrow Cvc Set 3-Lumen 7 Fr X 30 Cm | 338 | 12 | 0% |
| Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm | 1,406 | 170 | 0.1% |
| Arrow Pi Cvc Kit 3-L 7 Fr X 20 Cm Agb | 286 | 63 | 1% |
| Liberty Select Cycler | 589 | 0 | 4.8% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Mahurkar reports
How many FDA reports name Mahurkar?
1,046 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 6 in the latest 12 months.
What kinds of events are reported?
malfunction (92.4%), injury (6.6%) and death (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material puncture/hole (25%), break (17.2%), difficult to remove (15.1%), product quality problem (11.2%) and obstruction of flow (8.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.6%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Mahurkar was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.