MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-05-08 for BACTEC LYTIC/10 ANAEROBIC/F MEDIUM 442265 manufactured by Bd Caribe, Ltd..
[1140849]
A positive blood culture vial was broken during removal from the hospital's bactec instrument. Although the technician was using forceps to remove the glass pieces from the instrument, a small glass piece punctured her glove and pierced her finger. The technician was referred to the hospital nurse for treatment. She received a tetanus shot and was prescribed antibiotics as prophylaxis due to the positivity of the culture. At a later date the antibiotic was changed due to the organism being resistant to the antibiotic originally prescribed. The tech did not have an identification for the organism that was isolated from the blood culture.
Patient Sequence No: 1, Text Type: D, B5
[8456768]
Although the technician was wearing personal protective equipment and was using forceps, she was still pierced by the broken glass. She received a tetanus and antibiotics. No investigation regarding the 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 | 1119779-2009-00006 |
| MDR Report Key | 1378317 |
| Report Source | 05 |
| Date Received | 2009-05-08 |
| Date of Report | 2009-05-07 |
| Date of Event | 2009-04-24 |
| Date Mfgr Received | 2009-04-24 |
| Date Added to Maude | 2011-03-21 |
| 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 DRIVE, 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 | 2009-05-08 |
| 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 | 2009-05-08 |