MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-23 for PCA CARTRIDGES * manufactured by Abbott.
[17483558]
Abbott has verbally and via email notified facility that the empty pca cartridges used for non-commercially available pharmaceuticals as morphine have been placed on a national back order until jan. 2004. At this time, no specific medication safety issues have arisen as the reporter's inventory has not been depleted. Usual safety concerns will occur when transitioning over the use of alternative pca devices, which may be greater than normal due to the relatively tight timeline to react to the situation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1030652 |
| MDR Report Key | 506387 |
| Date Received | 2003-12-23 |
| Date Added to Maude | 2004-01-16 |
| 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 | 3 |
| 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 | PCA CARTRIDGES |
| Generic Name | PCA CARTRIDGES |
| Product Code | DIF |
| Date Received | 2003-12-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 495258 |
| Manufacturer | ABBOTT |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-23 |