Devices › Catheter, hemodialysis, implanted
Device brand name · Dialysis catheter
HemoSplit Catheter: medical device reports filed with FDA
249 reports name it, 2003–2026. Manufacturer given most often on reports: C R Bard Basd -3006260740. Product code MSD.
- 249
- device reports naming the brand
- 0% of all MAUDE reports · about 11 a year
- 49
- reports, 12 months to August 2026
- 72 in the 12 months before
- 76.7%
- classified as malfunction
- 75.8% across the product code
- 1.6%
- classified as death, as reported
- 4 reports · not verified by FDA
FDA's MAUDE database holds 249 reports that name the brand "HemoSplit Catheter" (dialysis catheter), received between August 2003 and August 2026; the manufacturer given most often on reports is C R Bard Basd -3006260740. Spellings of one product vary from report to report.
49 reports arrived in the 12 months to August 2026, down 32% from 72 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 (76.7%), injury (21.7%) and death (1.6%); across all catheter, hemodialysis, implanted reports (product code MSD) death is recorded in 2.6% 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 fracture (21.7%), deformation due to compressive stress (18.5%) and restricted flow rate (10.4%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, thrombosis/thrombus and hemorrhage/blood loss/bleeding. 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 11,458 reports carrying product code MSD. 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 |
|---|---|---|---|
| Fracturea broken bone | 54 | 21.7% | 6.7% |
| Deformation due to compressive stress | 46 | 18.5% | 4.1% |
| Restricted flow rate | 26 | 10.4% | 2.1% |
| Fluid/blood leak | 25 | 10% | 10.4% |
| Material separation | 17 | 6.8% | 3.9% |
| Crackthe device cracked | 12 | 4.8% | 9.4% |
| Material opacification | 12 | 4.8% | 1.6% |
| Suction problem | 12 | 4.8% | 1.2% |
| Failure to advance | 9 | 3.6% | 0.9% |
| Stretched | 9 | 3.6% | 1.5% |
| Air/gas in device | 8 | 3.2% | 1.1% |
| Material deformation | 8 | 3.2% | 3.4% |
| Melted | 8 | 3.2% | 0.2% |
| Material integrity problema problem with the device material | 7 | 2.8% | 1.4% |
| Obstruction of flow | 7 | 2.8% | 1.4% |
| Packaging problem | 7 | 2.8% | 0.4% |
| Unsealed device packaging | 7 | 2.8% | 0.2% |
| Detachment of device or device componentpart of the device came off | 6 | 2.4% | 2% |
| Expulsion | 6 | 2.4% | 1.2% |
| Improper or incorrect procedure or method | 6 | 2.4% | 0.4% |
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 |
|---|---|---|
| Appropriate clinical signs, symptoms and conditions term/code not available | 30 | 12% |
| Thrombosis/thrombus | 10 | 4% |
| Hemorrhage/blood loss/bleeding | 9 | 3.6% |
| Bacterial infectiona bacterial infection | 3 | 1.2% |
| Cardiac tamponade | 2 | 0.8% |
| Fever | 2 | 0.8% |
| Hemothorax | 2 | 0.8% |
| Low blood pressure/ hypotension | 2 | 0.8% |
| Obstruction/occlusion | 2 | 0.8% |
| Painpain, site not specified | 2 | 0.8% |
| Stenosis | 2 | 0.8% |
| Air embolism | 1 | 0.4% |
| Anxietyanxiety | 1 | 0.4% |
| Arrhythmia | 1 | 0.4% |
| Cardiac arrestthe heart stopped | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | HemoSplit Catheter | Product code MSD | All MAUDE reports |
|---|---|---|---|
| Reports | 249 | 11,458 | 26,136,888 |
| Share of that pool | — | 2.2% | 0% |
| Classified as death, per 1,000 reports | 16 | 26 | 9 |
| Classified as injury | 21.7% | 20% | 36.2% |
| Classified as malfunction | 76.7% | 75.8% | 62.3% |
| Filed by the manufacturer | 99.6% | 94.7% | 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 MSD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Palindrome | 1,473 | 52 | 1.3% |
| GlidePath | 775 | 225 | 0.9% |
| HemoStar | 361 | 84 | 0.8% |
| Lifesite Hemodialysis Access System | 342 | 0 | 6.4% |
| Equistream Split Tip | 296 | 125 | 0% |
| Arrow Hemodialysis Kit 2-L 15 Fr X 19 Cm | 267 | 40 | 0.4% |
| Ash Split Catheter | 258 | 0 | 3.5% |
| Dialysis Unknown | 402 | 6 | 5% |
| Mahurkar | 1,046 | 6 | 1.1% |
| Angiodynamics / Bioflo | 163 | 0 | 0% |
| Vaxcel Pasv Picc | 286 | 0 | 0.7% |
| Bardia Foley Catheter Silicone Coated | 2,420 | 193 | 0% |
| AngioDynamics | 174 | 14 | 1.7% |
| Cadd Ms3 Pump | 719 | 0 | 0% |
| Fresenius Dialysis Delivery System | 364 | 0 | 11% |
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 HemoSplit Catheter reports
How many FDA reports name HemoSplit Catheter?
249 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 49 in the latest 12 months.
What kinds of events are reported?
malfunction (76.7%), injury (21.7%) and death (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (21.7%), deformation due to compressive stress (18.5%), restricted flow rate (10.4%), fluid/blood leak (10%) and material separation (6.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that HemoSplit Catheter 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.