Devices › Catheter, hemodialysis, implanted
Device brand name · Hemodialysis catheter
Ash Split Catheter: medical device reports filed with FDA
258 reports name it, 1999–2004. Manufacturer given most often on reports: Medcomp. Product code MSD.
- 258
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 12.8%
- classified as malfunction
- 75.8% across the product code
- 3.5%
- classified as death, as reported
- 9 reports · not verified by FDA
FDA's MAUDE database holds 258 reports that name the brand "Ash Split Catheter" (hemodialysis catheter), received between February 1999 and December 2004; the manufacturer given most often on reports is Medcomp. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 injury (82.9%), malfunction (12.8%) and death (3.5%); 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 explanted (47.7%), crack (29.1%) and leak/splash (19.4%). The patient problems coded most often are surgical procedure, therapy/non-surgical treatment, additional and surgical procedure, repeated. 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
No report naming Ash Split Catheter was received in the five years to August 2026; the latest was received in December 2004.
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 |
|---|---|---|---|
| Explanted | 123 | 47.7% | 7.6% |
| Crackthe device cracked | 75 | 29.1% | 9.4% |
| Leak/splashthe device leaked | 50 | 19.4% | 8.6% |
| Replace | 37 | 14.3% | 3.4% |
| Material separation | 22 | 8.5% | 3.9% |
| Repair | 15 | 5.8% | 0.4% |
| Hole in material | 14 | 5.4% | 2.9% |
| Dislodged | 13 | 5% | 0.3% |
| Breakthe device broke | 12 | 4.7% | 11.3% |
| Tears, rips, holes in device, device material | 11 | 4.3% | 0.9% |
| Other (for use when an appropriate device code cannot be identified) | 9 | 3.5% | 0.6% |
| Component(s), broken | 8 | 3.1% | 0.7% |
| Device remains implanted | 7 | 2.7% | 0.8% |
| Split | 7 | 2.7% | 0.8% |
| Fluid/blood leak | 6 | 2.3% | 10.4% |
| Migration or expulsion of device | 6 | 2.3% | 1.9% |
| Air leak | 5 | 1.9% | 1.3% |
| Detachment of device component | 5 | 1.9% | 2.9% |
| Device issuea problem with the device | 5 | 1.9% | 0.2% |
| Defective devicethe device was defective | 4 | 1.6% | 0.3% |
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 |
|---|---|---|
| Surgical procedure | 73 | 28.3% |
| Therapy/non-surgical treatment, additional | 35 | 13.6% |
| Surgical procedure, repeated | 17 | 6.6% |
| Surgical procedure, additional | 13 | 5% |
| Blood loss | 12 | 4.7% |
| Deaththe patient died; cause not stated by this term | 9 | 3.5% |
| Bleeding | 7 | 2.7% |
| Hospitalization required | 7 | 2.7% |
| Failure of implant | 6 | 2.3% |
| Resuscitation | 5 | 1.9% |
| Air embolism | 3 | 1.2% |
| Cardiac arrestthe heart stopped | 3 | 1.2% |
| Cardiopulmonary arrest | 3 | 1.2% |
| Foreign body, removal of | 3 | 1.2% |
| Therapy/non-surgical treatment, aborted/stopped | 3 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ash Split Catheter | Product code MSD | All MAUDE reports |
|---|---|---|---|
| Reports | 258 | 11,458 | 26,136,888 |
| Share of that pool | — | 2.3% | 0% |
| Classified as death, per 1,000 reports | 35 | 26 | 9 |
| Classified as injury | 82.9% | 20% | 36.2% |
| Classified as malfunction | 12.8% | 75.8% | 62.3% |
| Filed by the manufacturer | 95.3% | 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% |
| HemoSplit Catheter | 249 | 49 | 1.6% |
| 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 Ash Split Catheter reports
How many FDA reports name Ash Split Catheter?
258 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (82.9%), malfunction (12.8%) and death (3.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (47.7%), crack (29.1%), leak/splash (19.4%), replace (14.3%) and material separation (8.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.3%) and voluntary reports (1.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ash Split 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.