MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1997-10-08 for ONE-WAY MALE FLOW VALVE 396798 manufactured by Rusch, Inc..
[15260729]
It was stated that valve is not seating correctly causing a back flow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1997-00094 |
| MDR Report Key | 125479 |
| Report Source | 06,07 |
| Date Received | 1997-10-08 |
| Date of Report | 1997-10-08 |
| Date Mfgr Received | 1997-10-07 |
| Date Added to Maude | 1997-10-14 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE-WAY MALE FLOW VALVE |
| Generic Name | ADAPTER |
| Product Code | CBP |
| Date Received | 1997-10-08 |
| Model Number | NA |
| Catalog Number | 396798 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 122829 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US |
| Baseline Brand Name | FEMALE VALVE |
| Baseline Generic Name | ADAPTER - VALVE |
| Baseline Model No | NA |
| Baseline Catalog No | 396798 |
| Baseline ID | NA |
| Baseline Device Family | VALVE, NON-REBREATHING |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K925893 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-08 |