MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-01-30 for BD BACTEC CULTURE VIAL UNK manufactured by Bd Caribe, Ltd..
[16002601]
The broken vial was located in the facility's pneumatic tube system. The customer had implemented a protocol to wrap the bottle in bubble wrap and seal it in a plastic bag and has verified that this practice was utilized when this incident occurred. The customer has asked to reevaluate using the pneumatic tube vial holder which is designed for transporting bactec bottles in pneumatic tube systems. Bactec bottles are available in a variety of different media formulations and fill volumes. No investigation regarding the bottle could be conducted due to the inability to retrieve a catalog number or 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
[16098997]
A blood culture vial was broken in the hospital's pneumatic tube system. A staff member cut herself on the broken bottle. She did not require stitches but is currently receiving prophylaxis for (b)(6). The treatment is making her sick and she is currently on leave. The facility will not confirm if the blood she was exposed to was (b)(6). They refuse to provide add'l treatment details at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2009-00002 |
| MDR Report Key | 2534425 |
| Report Source | 05 |
| Date Received | 2009-01-30 |
| Date of Report | 2009-01-30 |
| Date of Event | 2009-01-06 |
| Date Mfgr Received | 2009-01-06 |
| Date Added to Maude | 2012-04-17 |
| 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 | JAMES TILLMAN |
| Manufacturer Street | 7 LOVETON CIRCLE |
| 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 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BACTEC CULTURE VIAL |
| Product Code | JTA |
| Date Received | 2009-01-30 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2009-01-30 |