MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-08 for BD BACTEC PLUS AEROBIC/F CULTURE VIAL 442192 manufactured by Bd Caribe, Ltd.
[827841]
A blood culture vial was broken in the bactec blood culture instrument. While removing the broken vial from the instrument, an employee splashed blood in her eye. The employee received medical attention through the er and employee services.
Patient Sequence No: 1, Text Type: D, B5
[7995344]
The broken vial was located in the top of the bactec in a 2 tier instrument set up. Lab personnel were wearing labcoats and gloves but no eye protection while removing the broken vial. The employee's eye was flushed and no add'l prophylaxis was administered. No investigation regarding the bottle was conducted due to the inability to retrieve the lot number of the broken bactec blood culture vial. Bd will continue to monitor this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2008-00006 |
| MDR Report Key | 1026102 |
| Report Source | 05 |
| Date Received | 2008-04-08 |
| Date of Report | 2008-04-04 |
| Date of Event | 2008-03-11 |
| Date Mfgr Received | 2008-03-11 |
| Date Added to Maude | 2008-09-17 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | BD CARIBE, LTD |
| Manufacturer Street | VICKS DR, LOT #6 |
| Manufacturer City | CAYEY PR 00737 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00737 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BACTEC PLUS AEROBIC/F CULTURE VIAL |
| Product Code | JTA |
| Date Received | 2008-04-08 |
| Catalog Number | 442192 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1024955 |
| Manufacturer | BD CARIBE, LTD |
| Manufacturer Address | CAYEY PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-04-08 |