MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-17 for BACTEC PLUS ANAEROBIC/F MEDIUM 442193 manufactured by Bd Caribe, Ltd..
[1254503]
A technician was removing a bottle from the instrument and the bottle broke. The technician was wearing a lab coat and gloves but did receive a cut. She received a tetanus shot. No other information was available.
Patient Sequence No: 1, Text Type: D, B5
[8502534]
Retention samples from the same lot were visually inspected for any broken and/or cracked vials. All results were satisfactory. Review of the batch history record did not identify abnormalities as related to this issue. Although bd is unable to confirm any issues that would have contributed to this event, we will continue to closely monitor this type of issue. Bd will continue to educate the customer concerning proper handling of bactec bottles and any breakage that may occur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2009-00012 |
| MDR Report Key | 1562890 |
| Report Source | 05 |
| Date Received | 2009-12-17 |
| Date of Report | 2009-12-16 |
| Date of Event | 2009-12-09 |
| Date Mfgr Received | 2009-12-09 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2011-04-08 |
| 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 PLUS ANAEROBIC/F MEDIUM |
| Product Code | JSL |
| Date Received | 2009-12-17 |
| Catalog Number | 442193 |
| Lot Number | 9257200 |
| Device Expiration Date | 2010-09-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2009-12-17 |