Devices › Catheter, hemodialysis, implanted
Device brand name · Dialysis catheter
Equistream Split Tip: medical device reports filed with FDA
296 reports name it, 2021–2026. Manufacturer given most often on reports: C R Bard Basd -3006260740. Product code MSD.
- 296
- device reports naming the brand
- 0% of all MAUDE reports · about 56 a year
- 125
- reports, 12 months to August 2026
- 70 in the 12 months before
- 85.8%
- classified as malfunction
- 75.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
296 medical device reports received by FDA name the brand "Equistream Split Tip" (dialysis catheter); the manufacturer given most often on reports is C R Bard Basd -3006260740; received from April 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
125 reports arrived in the 12 months to August 2026, up 79% from 70 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 (85.8%) and injury (14.2%); 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 deformation due to compressive stress (49.3%), fracture (20.6%) and restricted flow rate (15.5%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, hemorrhage/blood loss/bleeding and air embolism. 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 |
|---|---|---|---|
| Deformation due to compressive stress | 146 | 49.3% | 4.1% |
| Fracturea broken bone | 61 | 20.6% | 6.7% |
| Restricted flow rate | 46 | 15.5% | 2.1% |
| Fluid/blood leak | 42 | 14.2% | 10.4% |
| Suction problem | 29 | 9.8% | 1.2% |
| Material opacification | 28 | 9.5% | 1.6% |
| Difficult to flush | 23 | 7.8% | 0.5% |
| Degraded | 21 | 7.1% | 0.3% |
| Obstruction of flow | 18 | 6.1% | 1.4% |
| Stretched | 17 | 5.7% | 1.5% |
| Material protrusion/extrusion | 14 | 4.7% | 1.3% |
| Air/gas in device | 13 | 4.4% | 1.1% |
| Material separation | 12 | 4.1% | 3.9% |
| Material puncture/hole | 9 | 3% | 3.2% |
| Collapse | 8 | 2.7% | 0.5% |
| Failure to advance | 8 | 2.7% | 0.9% |
| Packaging problem | 8 | 2.7% | 0.4% |
| Difficult to removethe device was hard to remove | 7 | 2.4% | 2.1% |
| Improper or incorrect procedure or method | 6 | 2% | 0.4% |
| Material integrity problema problem with the device material | 6 | 2% | 1.4% |
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 | 28 | 9.5% |
| Hemorrhage/blood loss/bleeding | 5 | 1.7% |
| Air embolism | 4 | 1.4% |
| Extravasation | 2 | 0.7% |
| Bacterial infectiona bacterial infection | 1 | 0.3% |
| Discomfortdiscomfort | 1 | 0.3% |
| Embolism/embolus | 1 | 0.3% |
| Nerve damage | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Equistream Split Tip | Product code MSD | All MAUDE reports |
|---|---|---|---|
| Reports | 296 | 11,458 | 26,136,888 |
| Share of that pool | — | 2.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 26 | 9 |
| Classified as injury | 14.2% | 20% | 36.2% |
| Classified as malfunction | 85.8% | 75.8% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| Arrow Hemodialysis Kit 2-L 15 Fr X 19 Cm | 267 | 40 | 0.4% |
| HemoSplit Catheter | 249 | 49 | 1.6% |
| 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 Equistream Split Tip reports
How many FDA reports name Equistream Split Tip?
296 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 125 in the latest 12 months.
What kinds of events are reported?
malfunction (85.8%) and injury (14.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
deformation due to compressive stress (49.3%), fracture (20.6%), restricted flow rate (15.5%), fluid/blood leak (14.2%) and suction problem (9.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Equistream Split Tip 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.