BD BBL¿ ENRICHED THIOGLYCOLLATE MEDIUM
Report
- Report Number
- 1119779-2025-00018
- Event Type
- Injury
- Date Received
- January 30, 2025
- Date of Event
- December 30, 2024
- Report Date
- March 19, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- UDI-DI
- 30382902217870
- PMA / PMN Number
- K803023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY - MATERIAL 221787 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW FOR BATCH 4213637 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE, WHICH INCLUDED PHYSICAL ATTRIBUTES OF THE TUBES. THE COMPLAINT HISTORY WAS REVIEWED, AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 4213637. RETENTION SAMPLES FOR BATCH 4213637 (10 TUBES) WERE AVAILABLE FOR INSPECTION. THERE WERE 0/10 BROKEN OR CRACKED TUBES FOUND DURING INSPECTION. THERE WERE NO PHOTOS OR RETURNS AVAILABLE FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND FOR DEFECTS. BD SHIPS PRODUCT IN TEMPERATURE-CONTROLLED TRUCKS TO DISTRIBUTION CENTERS. DISTRIBUTION CENTERS ARE PROVIDED WITH SHIPPING AND STORAGE GUIDELINES. MISHANDLING OF THE PRODUCT AND VIBRATIONS DURING SHIPPING CAN CAUSE CRACKED OR BROKEN TUBES.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING BD BBL¿ ENRICHED THIOGLYCOLLATE MEDIUM, A STAFF MEMBER WAS TRANSFERRING A PATIENT'S POSITIVE BLOOD CULTURE SAMPLE INTO ONE (1) GLASS TUBE WHEN THE NECK OF THE TUBE BROKE. THE STAFF MEMBER AFTER BEING CUT AND PIERCED, WENT TO A MEDICAL INSTITUTION FOR A BLOOD TEST AND ARE BEING MONITORED. THE PATIENT WHO HAD THE POSITIVE BLOOD CULTURE DID NOT HAVE ANY INFORMATION ABOUT HBV OR HCV INFECTION, SO EVEN IF THE STAFF MEMBER HAD COME INTO CONTACT WITH THE BLOOD, THE RISK OF INFECTION IS THOUGHT TO BE LOW.
IT WAS REPORTED WHEN USING BD BBL¿ ENRICHED THIOGLYCOLLATE MEDIUM, A STAFF MEMBER WAS TRANSFERRING A PATIENT'S POSITIVE BLOOD CULTURE SAMPLE INTO ONE (1) GLASS TUBE WHEN THE NECK OF THE TUBE BROKE. THE STAFF MEMBER AFTER BEING CUT AND PIERCED, WENT TO A MEDICAL INSTITUTION FOR A BLOOD TEST AND ARE BEING MONITORED. THE PATIENT WHO HAD THE POSITIVE BLOOD CULTURE DID NOT HAVE ANY INFORMATION ABOUT HBV OR HCV INFECTION, SO EVEN IF THE STAFF MEMBER HAD COME INTO CONTACT WITH THE BLOOD, THE RISK OF INFECTION IS THOUGHT TO BE LOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441720 | BD BBL¿ ENRICHED THIOGLYCOLLATE MEDIUM | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON DICKINSON & CO. (SPARKS) | 4213637 | 30382902217870 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |