MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-03-19 for BD BACTEC 12B MYCOBACTERIA CULTURE VIALS MIDD 442004 manufactured by Bd Diagnostic Systems.
[20923302]
An employee in a research facility dropped and broke a bactec 12b vial outside of the bactec 460 instrument/ hood which contained cdc strain 1551, m. Tuberculosis. The lab exposed this strain to isoniazid, rifampin or other drugs for 40 days to select resistant strains. According to the customer, most of the time such 12b vials are non-viable although they may give growth index (gi) readings in the hundreds. The broken vial had a gi in the hundreds but the lab does not know if the organism is viable or not. The employee was not wearing an n95 or equivalent mask/respirator. The bactec 460 instrument is not contained in a bsl3 laboratory. The employee soaked lab diapers in 10% bleach, laid them over the breakage, closed the door and left the room. She took an emergency shower and autoclaved her boots. The hazmat team arrived 30 minutes later with proper ppe and decontaminated and scrubbed the area to remove radioactivity. A c14 swipe test was negative following the cleaning. The employee who broke the vial was given a baseline ppd which was negative.
Patient Sequence No: 1, Text Type: D, B5
[21233620]
Bactec 12b mycobacteria medium is recommended for the culture and recovery of mycobacteria from multiple specimen sources, differentiation of the m. Tuberculosis complex from other mycobacteria and drug susceptibility testing of m. Tuberculosis. The bactec 12b bottles contain radioactive substrates tagged with c-14, but there is no risk of serious injury after brief exposure to c-14 at the trace levels used in the bactec media. As stated in the msds, flushing/rinsing any exposed skin or eyes with water is an adequate first aid measure to eliminate any health risks from this hazardous component. The cleanup process used by the hazmat team was adequate to reduce any further risk of c-14 contamination in the area of the spill. This strain of tuberculosis is a highly immunogenic outbreak strain from humans in the 1990's when it had a high rate of transmission and virulence. In this event, the researchers created potentially resistant organisms. Gi readings could indicate organism growth and viability. With drug resistant tb, there is a potential for serious injury or even death to any accidentally exposed individuals. Since the associate was not wearing ppe there is the potential for exposure as well as a risk of potential aerosol exposure after the breakage in a non bsl 3 lab. The appropriate action was taken to obtain a baseline line status (tb skin test) on the researcher, so that a subsequent conversion could be noted and treated appropriately. A batch history record could not be reviewed as no lot number was available. Returns were unavailable. Several lots of 12b vials were examined for cracks. No cracked or broken vials were observed. Complaint trend analysis revealed this issue to be an isolated incident. Quality will continue to trend the system for this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2010-00002 |
| MDR Report Key | 1640196 |
| Report Source | 00 |
| Date Received | 2010-03-19 |
| Date of Report | 2010-03-19 |
| Date of Event | 2010-03-04 |
| Date Mfgr Received | 2010-03-04 |
| 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 |
| 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 Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BACTEC 12B MYCOBACTERIA CULTURE VIALS MIDD |
| Product Code | JTA |
| Date Received | 2010-03-19 |
| Catalog Number | 442004 |
| Lot Number | UNK |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-19 |