MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-10 for BLOOD CULTURE COLLECTION ADAPTER (BACTEC ALERT) 59650 manufactured by Organon Teknika.
[16032443]
While drawing last of second set of cultures, the luer adapter popped off from direct draw cap causing the phlebotimist to stick her left thumb while trying in insure the patient did not ge stuck. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25645 |
| MDR Report Key | 25645 |
| Date Received | 1995-01-10 |
| Date of Report | 1994-12-31 |
| Report Date | 1994-12-31 |
| Date Added to Maude | 1995-09-14 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOOD CULTURE COLLECTION ADAPTER (BACTEC ALERT) |
| Product Code | FKB |
| Date Received | 1995-01-10 |
| Catalog Number | 59650 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 26221 |
| Manufacturer | ORGANON TEKNIKA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. No Informationnvalid Deathata | 1995-01-10 |