MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-07 for DAVOL, SUBSIDIARY OF C.R. BARD 60268 manufactured by Bard Access Systems, Inc..
[5628]
Port-a-cath implanted 4/16/93, tip sheared off in vein 9/7/93. Tip lodged in left pulmonary circulation from which it was removed successfully the same day. Surgical intervention was required. Manufacturer was advised at the time, visited and investigated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16623 |
| MDR Report Key | 16623 |
| Date Received | 1994-02-07 |
| Date of Report | 1993-12-31 |
| Date of Event | 1993-09-07 |
| Date Added to Maude | 1994-10-06 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAVOL, SUBSIDIARY OF C.R. BARD |
| Generic Name | VENOUS ACCESS DEVICE, CATHETER W/RESERVOIR |
| Product Code | LKG |
| Date Received | 1994-02-07 |
| Model Number | 60268 |
| Catalog Number | 60268 |
| Lot Number | 36AD1842 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16556 |
| Manufacturer | BARD ACCESS SYSTEMS, INC. |
| Manufacturer Address | 5425 WEST AMELIA EARHART DR. SALT LAKE CITY UT 84116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1994-02-07 |