MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-27 for ANAEROBIC CULTURE BOTTLES 59269 * manufactured by Organon Teknika Corp..
[108330]
Two blood culture bottles have the same bar-coded number. These two bottles belong to the same lot and have an expiration date 09/19/98. User became aware of situation when the blood culture machine indicated a warning concerning the same bar code for two different pts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013080 |
| MDR Report Key | 153510 |
| Date Received | 1998-02-27 |
| Date of Report | 1998-02-17 |
| Date of Event | 1998-01-21 |
| Date Added to Maude | 1998-03-04 |
| 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 |
| 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 | ANAEROBIC CULTURE BOTTLES |
| Generic Name | BLOOD CULTURE BOTTLE |
| Product Code | JSL |
| Date Received | 1998-02-27 |
| Model Number | 59269 |
| Catalog Number | * |
| Lot Number | 208414 |
| ID Number | * |
| Device Expiration Date | 1998-09-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 149548 |
| Manufacturer | ORGANON TEKNIKA CORP. |
| Manufacturer Address | 100 AKZO AVE. DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-02-27 |