MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-20 for * N-7990 manufactured by Mcgaw, Inc..
[17513025]
After reconstitution of unasyn using binary connector, the seal went back into hole so solution of drug could not be released from vial to minibag decreasing dose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012309 |
| MDR Report Key | 127506 |
| Date Received | 1997-10-20 |
| Date of Report | 1997-10-20 |
| Date of Event | 1997-10-16 |
| Date Added to Maude | 1997-10-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | BINARY CONNECTOR |
| Product Code | LHF |
| Date Received | 1997-10-20 |
| Model Number | * |
| Catalog Number | N-7990 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 124754 |
| Manufacturer | MCGAW, INC. |
| Manufacturer Address | 2525 MCGAW AVE IRVINE CA 926145895 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-20 |