MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-02-17 for PICC UNK manufactured by C.r. Bard, Inc. (basd).
[3564704]
Left svc thrombosis around tip of catheter. Pt needed thrombolysis.
Patient Sequence No: 1, Text Type: D, B5
[10725112]
The complaint is inconclusive since the product was discarded and will not be returned for eval. A complaint history review could not be completed since the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1720496-2006-00063 |
| MDR Report Key | 3126383 |
| Report Source | 06 |
| Date Received | 2006-02-17 |
| Date of Report | 2006-02-02 |
| Date Reported to FDA | 2006-01-18 |
| Date Reported to Mfgr | 2006-01-18 |
| Date Mfgr Received | 2006-02-02 |
| Date Added to Maude | 2013-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | NITIN PATIL |
| Manufacturer Street | 5425 WEST AMELIA EARHART DR. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015950700 |
| Manufacturer G1 | UNK |
| Manufacturer Street | UNK |
| Manufacturer City | UNK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PICC |
| Generic Name | IMPLANTED LONG TERM INTRAVASCULAR |
| Product Code | OMF |
| Date Received | 2006-02-17 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (BASD) |
| Manufacturer Address | SALT LAKE CITY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-02-17 |