MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-10-17 for BACTEC STANDARD AEROBIC/F BLOOD CULTURE MEDIA 04402260 manufactured by Becton Dickinson Microbiology Systems.
[29775]
Customer was removing a positive vial from the instrument when the neck of the bottle snapped off. Customer was cut on the second finger of the right hand. Technician was wearing gloves but the glass cut through the golve. Bottle was confirmed positive for microbacteria on gram stain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1996-00003 |
| MDR Report Key | 43313 |
| Report Source | 05,06 |
| Date Received | 1996-10-17 |
| Date of Report | 1996-10-14 |
| Date of Event | 1996-08-12 |
| Date Added to Maude | 1996-10-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTEC STANDARD AEROBIC/F BLOOD CULTURE MEDIA |
| Generic Name | CULTURE MEDIA |
| Product Code | JSC |
| Date Received | 1996-10-17 |
| Model Number | NA |
| Catalog Number | 04402260 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 44280 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-10-17 |