MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-04-14 for BACTEC PLUS AEROBIC/F MEDIUM 442192 manufactured by Bd Caribe, Ltd.
[17919720]
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 were rec'd due to the nature of the complaint. 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
[17977896]
A technician was removing a bottle from the instrument when it broke and she was cut. The technician was wearing a lab coat and gloves when the vial pricked her finger. No stitches were required but she did receive a tetanus shot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2011-00002 |
| MDR Report Key | 2067179 |
| Report Source | 05 |
| Date Received | 2011-04-14 |
| Date of Report | 2011-03-28 |
| Date of Event | 2011-03-28 |
| Date Mfgr Received | 2011-03-28 |
| Date Added to Maude | 2011-04-26 |
| 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 | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| 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 AEROBIC/F MEDIUM |
| Product Code | JTA |
| Date Received | 2011-04-14 |
| Catalog Number | 442192 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-04-14 |