MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-19 for CHILD PROTECTIVE VIAL SET 16 CP SETS AMBER UNK manufactured by Porex Scientific.
[30154]
To ensure safety, childproof caps are supposed to be pushed down and turned in order to be opened. But in this situation, the caps were opened just by turning them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010294 |
| MDR Report Key | 50226 |
| Date Received | 1996-11-19 |
| Date of Report | 1996-11-19 |
| Date of Event | 1996-11-18 |
| Date Added to Maude | 1996-11-21 |
| 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 | CHILD PROTECTIVE VIAL SET |
| Generic Name | VIAL WITH CHILDPROOF LID |
| Product Code | NXB |
| Date Received | 1996-11-19 |
| Model Number | 16 CP SETS AMBER |
| Catalog Number | UNK |
| Lot Number | 61029A |
| ID Number | PART # A32016 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 50939 |
| Manufacturer | POREX SCIENTIFIC |
| Manufacturer Address | 15 DART RD NEWNAN GA 302631017 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-11-19 |