DOT PROV 4F DL MAX 3CG Adverse Event — Malfunction (MDR 3006260740-2020-01513)
DOT PROV 4F DL MAX 3CG Adverse Event — Malfunction (MDR 3006260740-2020-01513) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: DOT PROV 4F DL MAX 3CG; Generic name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30; Manufacturer: BARD ACCESS SYSTEMS.
| Device | DOT PROV 4F DL MAX 3CG |
|---|---|
| Generic name | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Report number | 3006260740-2020-01513 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, USER F |
| Narrative | THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REDY2966 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (REDY2966) HAVE BEEN REPORTED FROM THE SAME FACILITY. |
| Source | openFDA MAUDE (device adverse events) |
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