BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
Report
- Report Number
- 1119779-2023-00664
- Event Type
- Malfunction
- Date Received
- June 15, 2023
- Date of Event
- May 17, 2023
- Report Date
- August 14, 2025
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- UDI-DI
- 30382902217429
- PMA / PMN Number
- K803023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2023-05-26. H.6. INVESTIGATION SUMMARY: MATERIAL 221742 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. BATCH 3011171. THE BATCH HISTORY RECORD REVIEW FOR BATCH 3011171 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR IS REVIEWED TO CONFIRM THE FOLLOWING: --THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. --ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. --THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 3011171. RETENTION SAMPLES FROM BATCH 3011171 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10 RETENTION SAMPLES. ALL RETENTION TUBES HAD THE EXPECTED APPEARANCE FOR THIS PRODUCT OF LIGHT TO MEDIUM LIGHT YELLOW, TRACE HAZY TO CLEAR. TWO UNINOCULATED RETENTION TUBES FROM BATCH 3011171 WERE PLACED INTO INCUBATION. ONE RETENTION TUBE WAS PLACED INTO 20-25-DEGREES CELSIUS INCUBATOR AND ONE TUBE WAS PLACED INTO A 33-TO-37-DEGREE CELSIUS INCUBATOR. AT SEVEN DAYS INCUBATION, THERE WERE NO TRACES OF MICROBIAL GROWTH IN THE 2/2 INCUBATED RETENTION TUBES. BATCH 2279224. THE BATCH HISTORY RECORD REVIEW FOR BATCH 2279224 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR IS REVIEWED TO CONFIRM THE FOLLOWING: --THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. --ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. --THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 2279224. RETENTION SAMPLES FROM BATCH 2279224 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES. ALL RETENTION TUBES HAD THE EXPECTED APPEARANCE FOR THIS PRODUCT OF LIGHT TO MEDIUM LIGHT YELLOW, TRACE HAZY TO CLEAR. FOR INVESTIGATION, TWO RETENTION TUBES WENT INTO INCUBATION. ONE RETENTION TUBE WAS INCUBATED IN THE 20¿25-DEGREE CELSIUS INCUBATOR AND THE OTHER TUBE WAS PLACED IN THE 33¿37-DEGREE CELSIUS INCUBATOR. AT THE SEVENTH DAY OF INCUBATION THERE WERE NO SIGNS OF GROWTH OR TURBIDITY. BATCH 2325733. THE BATCH HISTORY RECORD REVIEW FOR BATCH 2325733 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUING , AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR IS REVIEWED TO CONFIRM THE FOLLOWING: --THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. --ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. --THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 2325733. RETENTION SAMPLES FROM BATCH 2325733 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES. TWO RETENTION TUBES WERE INCUBATED. ONE RETENTION TUBE WAS PLACED INTO 33-37-DEGREES CELSIUS INCUBATION, AND ONE RETENTION TUBE WAS PLACED INTO 20-25-DEGREES CELSIUS INCUBATION. AT THE END OF A SEVEN-DAY INCUBATION PERIOD THERE WAS NO CHANGE IN THE MEDIA COLOR AND CLARITY AND THERE WAS NO MICROBIAL GROWTH OBSERVED IN 2/2 INCUBATED RETENTION TUBES. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. A SMALL SHIPPING BOX WAS RECEIVED WITH 15 INDIVIDUALLY BUBBLE WRAPPED TUBES. FIVE TUBES WERE FROM BATCH 3011171, FIVE TUBES WERE FROM BATCH 2279224, AND FIVE TUBES WERE FROM BATCH 2325733. THE COLOR AND CLARITY OF 5/5 RETURNED TUBES FROM BATCH 3011171 THE MEDIA WAS MEDIUM YELLOW AND HAZY. THE COLOR AND CLARITY FROM THE 5/5 RETURNED TUBES FROM BATCH 2279224 WAS MEDIUM YELLOW HAZY WITH TINY FINE PARTICLES. ALL 5/5 RETURNED TUBES FROM BATCH 2325733 THE MEDIA COLOR AND CLARITY WAS MEDIUM YELLOW AND TRACE HAZY AS DESCRIBE IN THE CERTIFICATE OF ANALYSIS. ALL 15/15 RETURNED TUBES WERE PLACED INTO 33-37-DEGREES CELSIUS INCUBATION. AT THE END OF A SEVEN-DAY INCUBATION PERIOD THERE WAS NO CHANGE IN THE MEDIA COLOR AND CLARITY. ONE TUBE WAS PLATED ON TO TSA 5% SHEEP BLOOD AGAR FROM BATCH 3011171, 2279224, AND BATCH 2325733, AND NO ORGANISMS WERE RECOVERED. GRAM STAINS WERE ALSO PERFORMED ON BATCH 3011171, 2279224, AND BATCH 2279224. GRAM NEGATIVE RODS WERE OBSERVED FROM BATCH 3011171 AND BATCH 2279224, NO ORGANISMS WERE RECOVERED FROM BATCH 2325733. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION/APPEARANCE DEFECTS FOR BATCHES 3011171 AND 2279224 BASED ON THE EVIDENCE FROM THE RETURN SAMPLES RECEIVED. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION/APPEARANCE DEFECTS FROM BATCH 2325733 BASED ON THE EVIDENCE PROVIDED FROM THE RETURN SAMPLES RECEIVED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION/APPEARANCE/NON-VIABLES DEFECTS. BD HAS IDENTIFIED A COMPLAINT TREND FOR HAZY MEDIA DUE TO THE PRESENCE OF NON-VIABLES FOR THIS PRODUCT. H3 OTHER TEXT : SEE H.10.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2279224 D4. MEDICAL DEVICE EXPIRATION DATE: 2023-10-06 H4. DEVICE MANUFACTURE DATE: 2022-10-06 D4. MEDICAL DEVICE LOT #: 2325733 D4. MEDICAL DEVICE EXPIRATION DATE: 2023-11-18 H4. DEVICE MANUFACTURE DATE: 2022-11-21 D.3 COMMON DEVICE NAME: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL. 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 UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 3011171. B5. IT WAS REPORTED THAT WHILE USING THE BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, THERE WERE AN UNKNOWN NUMBER OF FALSE RESULTS DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR 11910483.
IT WAS REPORTED THAT WHILE USING THE BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCUBATED FOR 7 DAYS AT 37C. NOT VISUALLY TURBID PRIOR TO USE. BROTH SUBCULTURED TO BAP, CHOC, MAC AND CDC. GRAM STAIN PERFORMED MANUALLY AND AUTOMATICALLY. GRAM STAIN RESULT: "GRAM VARIABLE RODS- BOX CAR BACILLUS LOOKING". 3 BOXES RECEIVED - ALL 300 TUBES AFFECTED. WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT - NO ERRONEOUS RESULTS WERE REPORTED CUSTOMER REPORTS FINDING NON-VIABLE RODS WHEN GRAM STAINING THE THIO BROTH.
IT WAS REPORTED THAT WHILE USING THE BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCUBATED FOR 7 DAYS AT 37C NOT VISUALLY TURBID PRIOR TO USE BROTH SUBCULTURED TO BAP, CHOC, MAC AND CDC GRAM STAIN PERFORMED MANUALLY AND AUTOMATICALLY GRAM STAIN RESULT: "GRAM VARIABLE RODS- BOX CAR BACILLUS LOOKING" 3 BOXES RECEIVED - ALL 300 TUBES AFFECTED WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT - NO ERRONEOUS RESULTS WERE REPORTED CUSTOMER REPORTS FINDING NON-VIABLE RODS WHEN GRAM STAINING THE THIO BROTH.
IT WAS REPORTED THAT WHILE USING THE BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, THERE WERE AN UNKNOWN NUMBER OF FALSE RESULTS DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1956160 | BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN | SEE H.10 | JSG | BECTON, DICKINSON & CO. (SPARKS) | 221742 | 3011171 | 30382902217429 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |