MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-04-07 for BARD OVERPRESS.SAFETY VAL H130 manufactured by Bard Vascular System.
[20202361]
During the procedure the ops was found to be occluded. The perfusion could not pull back; air got into the line. The unit was removed and replaced to complete the procedure. This event had no adverse effects to the patient. The patient is reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222008-1998-00101 |
| MDR Report Key | 161937 |
| Report Source | 05,06 |
| Date Received | 1998-04-07 |
| Date of Report | 1998-03-12 |
| Date of Event | 1998-03-11 |
| Date Facility Aware | 1998-03-11 |
| Report Date | 1998-03-12 |
| Date Reported to FDA | 1998-04-06 |
| Date Mfgr Received | 1998-03-12 |
| Date Added to Maude | 1998-04-13 |
| 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 | BARD OVERPRESS.SAFETY VAL |
| Generic Name | OPS VALVE |
| Product Code | MNJ |
| Date Received | 1998-04-07 |
| Model Number | NA |
| Catalog Number | H130 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 157674 |
| 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 | 1998-04-07 |