MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-23 for BACTALERT AERO BIC CULTURE BOTTLE 59268 * manufactured by Organon Teknika.
[39730]
Employee was unloading a positive blood culture bottle from the blood culture instrument. Bottle apparently stuck in machine due to identifier label rolling up during insertion. When pulled on bottle to remove it, bottle broke at neck. Employee sustained 2 cm. Laceration to left index finger. Treated in emergency room: 6 sutures antibiotic (due to positive culture), and blood exposure follow-up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 64354 |
| MDR Report Key | 64354 |
| Date Received | 1996-12-23 |
| Date of Report | 1996-11-05 |
| Date of Event | 1996-10-31 |
| Date Facility Aware | 1996-10-31 |
| Report Date | 1996-11-05 |
| Date Reported to Mfgr | 1996-11-05 |
| Date Added to Maude | 1997-01-27 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTALERT AERO BIC CULTURE BOTTLE |
| Generic Name | BLOOD CULTURE SPECIMEN BOTTLE |
| Product Code | JSC |
| Date Received | 1996-12-23 |
| Model Number | 59268 |
| Catalog Number | * |
| Lot Number | 203634 |
| ID Number | * |
| Device Expiration Date | 1997-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 64491 |
| Manufacturer | ORGANON TEKNIKA |
| Manufacturer Address | P.O. BOX 15969 DURHAM NC 277040969 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-12-23 |