MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-10-16 for BACTEC PLUS AEROBIC/FBLOOD CULTURE MEDIA 4402192 manufactured by Becton Dickinson Microbiology Systems.
[29692]
Phlebotomist was exposed to blood after the neck of the bottle snapped off as she was ready to enter it into the instrument. She was not wearing gloves. She was not cut by the broken glass but has cracked skin at cuticle. She washed her hands and applied bleach immediately. Phlebotomist was taken to the er and received prophylactic medication and counseling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1996-00004 |
| MDR Report Key | 43206 |
| Report Source | 05,06 |
| Date Received | 1996-10-16 |
| Date of Report | 1996-10-14 |
| Date of Event | 1996-08-12 |
| Date Mfgr Received | 1996-08-21 |
| Device Manufacturer Date | 1996-05-01 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | UNK |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTEC PLUS AEROBIC/FBLOOD CULTURE MEDIA |
| Generic Name | CULTURE MEDIA |
| Product Code | JSC |
| Date Received | 1996-10-16 |
| Model Number | NA |
| Catalog Number | 4402192 |
| Lot Number | 0536E |
| ID Number | NA |
| Device Expiration Date | 1997-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 44177 |
| 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 | 1996-10-16 |