MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-29 for BARD NKA BECTON DICKINSON AND COMPANY 5613120 manufactured by Bard Nka Becton Dickinson And Company.
[177948563]
Dr was placing hd cath on pt. Upon removal of a guide wire the inner part of wire was removed while the outer coil peeled away and apparently broke off inside of pt. This was visualized on post line chest x-ray. The original catheter initially gave blood return but after placement there was no blood return. This catheter was removed and another was inserted without issue. Repeat x-ray still showed wire so a ct scan of chest was done and pt was scheduled to go to cath lab for removal of wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9672069 |
| MDR Report Key | 9672069 |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-20 |
| Date Facility Aware | 2020-01-20 |
| Report Date | 2020-01-28 |
| Date Reported to FDA | 2020-01-28 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | BARD NKA BECTON DICKINSON AND COMPANY |
| Generic Name | POWER-TRIALYSIS |
| Product Code | NIE |
| Date Received | 2020-01-29 |
| Model Number | 5613120 |
| Catalog Number | 5613120 |
| Lot Number | REDP1857 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD NKA BECTON DICKINSON AND COMPANY |
| Manufacturer Address | FRANKLIN LAKES NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-29 |