MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1998-01-16 for WILLIAM HARVEY H130 OPSV manufactured by Bard Vascular System.
[7786150]
Device failed performance pressure testing due to manufacturing process. A failure investigation and corrective preventive action implemented: fda was notified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222008-1998-00010 |
| MDR Report Key | 144562 |
| Report Source | 05,06,07 |
| Date Received | 1998-01-16 |
| Date of Report | 1997-12-24 |
| Date of Event | 1997-12-10 |
| Date Mfgr Received | 1997-12-24 |
| Date Added to Maude | 1998-01-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WILLIAM HARVEY H130 OPSV |
| Generic Name | OVERPRESSURE SAFETY VALV |
| Product Code | MNJ |
| Date Received | 1998-01-16 |
| Model Number | NA |
| Catalog Number | H130 |
| Lot Number | 43H9V106 |
| ID Number | NA |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 140948 |
| Manufacturer | BARD VASCULAR SYSTEM |
| Manufacturer Address | LAS PIEDRAS IND PK LOT #5 LAS PIEDRAS PR 00771 US |
| Baseline Brand Name | OVERPRESSURE SAFETY VALVE |
| Baseline Generic Name | OPS VALVE |
| Baseline Model No | NA |
| Baseline Catalog No | H130 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-16 |