MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-30 for BACTEC LYTIC/10 ANAEROBIC/F MEDIUM 442265 manufactured by Bd Caribe, Ltd..
[1114933]
A blood culture vial was broken during removal from the hospital's bactec instrument. The technician was splashed with blood and culture media in the face. She was wearing gloves and a lab coat but was not wearing safety glasses. Her face and eyes were run through running water for a minute and she was sent to employee health for follow up.
Patient Sequence No: 1, Text Type: D, B5
[8351234]
Conversation with the technician revealed that she was pulling a positive blood culture from the top instrument in one of the top racks. She is short in stature, so when she pulled on the bottle it splashed down onto her face, eyes and lab coat. A gram stain was done on the bottle with no organisms seen and no growth was observed from the subculture. The pt tested negative for (b)(6) in (b)(6). Technician indicated employee health drew blood and ran tests. No further test results or treatment details have been provided. No additional investigation regarding the culture bottle could be conducted due to the inability to retrieve a lot number of the broken bactec blood culture vial. No returns are received due to the nature of the complaint. Bd will continue to educate the customer concerning proper handling of bactec bottles and any breakage that may occur. Bd will continue to closely monitor this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2009-00007 |
| MDR Report Key | 1426307 |
| Report Source | 05 |
| Date Received | 2009-07-30 |
| Date of Report | 2009-07-29 |
| Date of Event | 2009-07-06 |
| Date Mfgr Received | 2009-07-06 |
| Date Added to Maude | 2011-03-29 |
| 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 | JAMES TILLMAN |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164054 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTEC LYTIC/10 ANAEROBIC/F MEDIUM |
| Product Code | JSL |
| Date Received | 2009-07-30 |
| Catalog Number | 442265 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD CARIBE, LTD. |
| Manufacturer Address | CAYEY PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-30 |