MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-11-18 for GROSHONG 4 FR PICC UNK manufactured by Bard Access Systems.
[19489428]
Peripherallly inserted central catheter placed and patient sent home. Pt returned a few days later with a leak near the exit site. Normal saline had leaked. Removed & replaced without difficulty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720496-1998-00345 |
| MDR Report Key | 198485 |
| Report Source | 07 |
| Date Received | 1998-11-18 |
| Date of Report | 1998-10-01 |
| Report Date | 1998-10-01 |
| Date Reported to Mfgr | 1998-10-01 |
| Date Mfgr Received | 1998-10-01 |
| Date Added to Maude | 1998-11-25 |
| 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 | 0 |
| 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 | GROSHONG 4 FR PICC |
| Generic Name | LONG TERM INTRAVASCULAR CATHETER |
| Product Code | LDQ |
| Date Received | 1998-11-18 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 192823 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 5425 W. AMELIA EARHART DR. SALT LAKE CITY UT 84116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-11-18 |