MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 1998-02-09 for BARD OVERPRES SAFETY VALVE H130 manufactured by Bard Vascular System.
[7779432]
Re-certification of manufacturing operations; corrective preventive action implemented.
Patient Sequence No: 1, Text Type: N, H10
[22078127]
The sterile bag containing the product was noted to have flaws/pin holes in it. The unit was not used in a clinical setting. No pt involvement or further complications occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222008-1998-00043 |
| MDR Report Key | 149003 |
| Report Source | 07,08 |
| Date Received | 1998-02-09 |
| Date of Report | 1998-01-19 |
| Date of Event | 1998-01-19 |
| Date Facility Aware | 1998-01-19 |
| Report Date | 1998-02-05 |
| Date Mfgr Received | 1998-01-19 |
| Date Added to Maude | 1998-02-18 |
| 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 | BARD OVERPRES SAFETY VALVE |
| Generic Name | OPS VALVE |
| Product Code | MNJ |
| Date Received | 1998-02-09 |
| Model Number | NA |
| Catalog Number | H130 |
| Lot Number | 43KHV112 |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 145210 |
| Manufacturer | BARD VASCULAR SYSTEM |
| Manufacturer Address | LAS PIEDRAS INDUSTRIAL PK 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 | 1998-02-09 |