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 12B 4402004 manufactured by Becton Dickinson Mucrobiology Systems.
[16144853]
Cytologist was attempting to inoculate a 12b vial with a fine needle aspirate from a liver abscess when the syringe came apart from the needle. The vial contents were forced out through the needle in a jet which sprayed into her face and eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1996-00002 |
| MDR Report Key | 43209 |
| Report Source | 05,06 |
| Date Received | 1996-10-16 |
| Date of Report | 1996-10-14 |
| Date of Event | 1996-09-10 |
| Date Mfgr Received | 1996-09-12 |
| Device Manufacturer Date | 1996-01-01 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTEC 12B |
| Generic Name | CULTURE MEDIA |
| Product Code | JSC |
| Date Received | 1996-10-16 |
| Model Number | NA |
| Catalog Number | 4402004 |
| Lot Number | A6J6 |
| ID Number | NA |
| Device Expiration Date | 1997-08-01 |
| 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 | 44179 |
| Manufacturer | BECTON DICKINSON MUCROBIOLOGY SYSTEMS |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-10-16 |