MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for MAHURKAR ELITE 8888222220 manufactured by Covidien Lp.
[174504472]
Patient was noted to be bleeding from the site of the dialysis catheter. Multiple interventions failed to stop the bleeding. Upon removal of the catheter, it was noted to be broken. It is not known when in the process the catheter broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9574804 |
| MDR Report Key | 9574804 |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-13 |
| Date of Event | 2019-12-03 |
| Report Date | 2019-12-13 |
| Date Reported to FDA | 2019-12-13 |
| Date Reported to Mfgr | 2020-01-10 |
| Date Added to Maude | 2020-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAHURKAR ELITE |
| Generic Name | CATHETER, HEMODIALYSIS, NON-IMPLANTED |
| Product Code | MPB |
| Date Received | 2020-01-10 |
| Model Number | 8888222220 |
| Catalog Number | 8888222220 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |