MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-27 for MAHURKAR DOUBLE LUMEN 12 FRENCH 20CM manufactured by Tyco Healthcare/kendall.
[802724]
A pt admitted with end stage liver disease and cholangitis and acute renal failure. Placement of vascath for dialysis complicated by catheter wire fragmenting when attempting removal through catheter. The wire could not be removed and entire procedure aborted and whole catheter removed. Line complication, secondary to device malfunction, resulting in subsequent bleeding from original site, and further interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005722 |
| MDR Report Key | 1005265 |
| Date Received | 2008-02-27 |
| Date of Report | 2008-02-27 |
| Date of Event | 2008-02-21 |
| Date Added to Maude | 2008-03-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAHURKAR DOUBLE LUMEN |
| Generic Name | VASCATH |
| Product Code | FFE |
| Date Received | 2008-02-27 |
| Catalog Number | 12 FRENCH 20CM |
| Lot Number | NKQ0214063130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 977635 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 15 HAMSPHIRE ST. MANSFIELD MA 00248 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-02-27 |