MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 1996-10-10 for OVER PRESSURE SAFETY VALV H130 manufactured by Bard Vascular Industrial Pk.
[21251351]
Blood leakage from the pressure relief valve during the operational procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222008-1996-00052 |
| MDR Report Key | 55056 |
| Report Source | 01,05,08 |
| Date Received | 1996-10-11 |
| Date of Report | 1996-09-11 |
| Date of Event | 1996-08-15 |
| Date Facility Aware | 1996-09-10 |
| Report Date | 1996-10-10 |
| Date Mfgr Received | 1996-09-10 |
| Date Added to Maude | 1996-12-13 |
| 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 | OVER PRESSURE SAFETY VALV |
| Generic Name | OPS |
| Product Code | KRI |
| Date Received | 1996-10-10 |
| Model Number | NA |
| Catalog Number | H130 |
| Lot Number | 43HFV108 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 55602 |
| Manufacturer | BARD VASCULAR INDUSTRIAL PK |
| Manufacturer Address | LAS PIEDRAS INDUSTRIAL PK LAS PIEDRAS PR 00771 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-11 |