BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
Report
- Report Number
- 1119779-2023-00672
- Event Type
- Malfunction
- Date Received
- June 16, 2023
- Date of Event
- May 30, 2023
- Report Date
- August 14, 2025
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- UDI-DI
- 30382902217887
- PMA / PMN Number
- K803023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: THIS COMPLAINT CAN BE CONFIRMED BY THE TREND. THE COMPLAINT HISTORY WAS REVIEWED, AND TWO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 3011172 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO CONTAMINATION OR TURBIDITY WAS OBSERVED IN 10/10 RETENTION SAMPLES. FOR INVESTIGATION, TWO RETENTION TUBES WENT INTO INCUBATION. ONE TUBE WAS INCUBATED IN THE 20-25 DEGREES CELSIUS, AND THE OTHER TUBE WAS PLACED IN THE 33¿37-DEGREE CELSIUS INCUBATOR. AT 7 DAYS INCUBATION, NO MICROBIAL GROWTH OR TURBIDITY WAS OBSERVED IN 2/2 INCUBATED TUBES. ONE PHOTO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION. THE PHOTO SHOWS TWO TUBES, ONE FROM BATCH 3011172 AND ONE TUBE FROM BATCH 2251073. THE TUBE FROM BATCH 3011172 DOES APPEAR TO BE HAZY IN CLARITY. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE CAUSE OF THE HAZY MEDIA IN THE PHOTO COULD NOT BE IDENTIFIED FROM THIS INVESTIGATION. HOWEVER, BD HAS IDENTIFIED A COMPLAINT TREND FOR HAZY MEDIA DUE TO THE PRESENCE OF NON-VIABLES FOR THIS PRODUCT. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) HAS BEEN INITIATED PER BD PROCEDURES. THE CAPA HAS COMPLETED EXECUTION OF CORRECTIVE ACTIONS. BD EXPECTS IMPROVEMENT IN THE OBSERVATION OF HAZY MEDIA DUE TO NON-VIABLES AS THE CAPA PROGRESSES. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION/APPEARANCE (TURBIDITY) DEFECTS. THIS COMPLAINT CAN BE CONFIRMED BY THE TREND.
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, A TUBE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
IT WAS REPORTED THAT WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN THERE WAS BIOLOGICAL CONTAMINATION. THIS OCCURRED ON TWENTY TUBES. NO ERRONEOUS RESULTS WERE PASSED ON TO THE CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BROTH IS TURBID AND GRAM-NEGATIVE RODS WERE DETECTED IN THE GRAM PREPARATION.
IT WAS REPORTED THAT WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN THERE WAS BIOLOGICAL CONTAMINATION. THIS OCCURRED ON TWENTY TUBES. NO ERRONEOUS RESULTS WERE PASSED ON TO THE CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BROTH IS TURBID AND GRAM-NEGATIVE RODS WERE DETECTED IN THE GRAM PREPARATION".
IT WAS REPORTED WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, A TUBE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692278 | BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 221788 | 3011172 | 30382902217887 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |