MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-07 for FAN AEROBIC CULTURE BOTTLES FAN AEROBIC BOTTLE 55948 manufactured by Organon Teknika Corp..
[18442724]
Blood was drawn from this pt and placed in a fan blood culture bottle. When the bottle was received in the lab, the bottom was noted to be yellow indicating a positive bottle. Less than 1 hr. Had elapsed from the time of collection to the time of receipt in the lab. Rptr concluded that the bottle must have been contaminated prior to inoculation. This appears to be a defective product from the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011852 |
| MDR Report Key | 111574 |
| Date Received | 1997-08-07 |
| Date of Report | 1997-08-06 |
| Date of Event | 1997-08-05 |
| Date Added to Maude | 1997-08-12 |
| 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 | FAN AEROBIC CULTURE BOTTLES |
| Generic Name | BLOOD CULTURE BOTTLE |
| Product Code | JSC |
| Date Received | 1997-08-07 |
| Returned To Mfg | 1997-08-07 |
| Model Number | FAN AEROBIC BOTTLE |
| Catalog Number | 55948 |
| Lot Number | 203899 |
| ID Number | * |
| Device Expiration Date | 1998-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 109560 |
| Manufacturer | ORGANON TEKNIKA CORP. |
| Manufacturer Address | 100 AKZO AVE. DURHAM NC 27704 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-08-07 |