BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
Report
- Report Number
- 1119779-2023-00018
- Event Type
- Malfunction
- Date Received
- January 11, 2023
- Date of Event
- January 5, 2023
- Report Date
- February 28, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- UDI-DI
- 30382902217429
- PMA / PMN Number
- K803023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. THE BATCH HISTORY RECORD REVIEW FOR BATCH 2279224 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. TORQUEING AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. 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 THIS BATCH. 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. A GRAM STAIN WAS PERFORMED AND NON-VIABLE GRAM-NEGATIVE RODS WERE OBSERVED UNDER THE MICROSCOPE. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. SIX TUBES FROM BATCH 2279224 WERE RECEIVED INSIDE OF A SHIPPING BAG ENVELOPE WITH TISSUE PAPER. ONE TUBE HAD A LOOSE CAP AND MEDIA LEAKED ON THE PACKAGE TISSUE PAPER AND THE LABELS OF THE OTHER FIVE TUBES WERE WET. THE OTHER FIVE TUBES HAD SECURE CAPS AND THE MEDIA DID APPEAR CLOUDY/HAZY. FOR FURTHER INVESTIGATION, ALL FIVE TUBES WERE INCUBATED. TWO RETURNED TUBES WENT INTO 20-25-DEGREE CELSIUS INCUBATION AND THREE RETURNED TUBES WENT INTO 33-37-DEGREE CELSIUS INCUBATION. AT THE END OF A SEVEN-DAY INCUBATION THERE WAS NO CHANGE IN THE MEDIA, THE MEDIA STILL APPEARED CLOUDY/HAZY. A GRAM STAIN WAS PERFORMED, AND NON-VIABLE GRAM-NEGATIVE RODS WERE OBSERVED UNDER THE MICROSCOPE. THIS COMPLAINT CAN BE CONFIRMED BASED ON THE EVIDENCE PROVIDED BY THE RETURNS RECEIVED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION/APPEARANCE DEFECTS/NON-VIABLES. CAUTION SHOULD BE EXERCISED IN REPORTING DIRECT GRAM STAIN AND/OR OTHER DIRECT MICROBIOLOGICAL STAIN RESULTS ON TISSUE SPECIMENS PROCESSED WITH THIS MEDIUM DUE TO THE POSSIBLE PRESENCE OF NONVIABLE ORGANISMS IN THE CULTURE MEDIUM. CULTURE MEDIA SOMETIMES CONTAIN DEAD ORGANISMS DERIVED FROM MEDIUM CONSTITUENTS, WHICH MAY BE VISIBLE IN SMEARS OF CULTURE MEDIA. IF THERE IS UNCERTAINTY ABOUT THE VALIDITY OF THE GRAM STAIN, THE CULTURE SHOULD BE RE-INCUBATED FOR ANOTHER HOUR OR TWO AND THE TEST REPEATED BEFORE A REPORT IS GIVEN. THE RETURNS FOR THIS BATCH SHOWED VISIBLE SEDIMENT THAT WAS DETERMINED TO BE NON-VIABLE ORGANISMS. THE AMOUNT OF SEDIMENT IN TUBES, WHEN DISTRIBUTED THROUGHOUT THE MEDIA, MAKES THE MEDIA APPEAR HAZY AND IS OUTSIDE OF THE CLARITY SPECIFICATION, OF LIGHT TO MEDIUM LIGHT YELLOW, TRACE HAZY TO CLEAR FOR THIS PRODUCT. WHILE NON-VIABLES ARE POSSIBLE IN THE MEDIA, THE AMOUNT OBSERVED HAS CREATED AN APPEARANCE DEFECT. A COMPLAINT TREND WAS NOT IDENTIFIED FOR CONTAMINATION, INCLUDING NON-VIABLES, OR APPEARANCE IN THIS PRODUCT PER BD PROCEDURES. NO ACTIONS ARE REQUIRED FOR THIS DEFECT AT THIS TIME. HOWEVER, BD STRIVES TO IMPROVE. A CROSS-FUNCTIONAL TEAM HAS BEEN ENGAGED TO INVESTIGATE THE MANUFACTURING AND INSPECTION PROCESS OF THIS PRODUCT WITH RESPECT TO POSSIBLE NON-VIABLE CONTAMINATION AND HAZY APPEARANCE OF THE MEDIA. POTENTIAL MANUFACTURING AND QUALITY TESTING IMPROVEMENTS HAVE BEEN IDENTIFIED AND ARE IN PROCESS.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN VIALS WERE FOUND OVERLY TURBID AND AFTER TESTING WAS DEEMED UNUSABLE FOR PATIENT TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBES RECEIVED 11/27 AND REFRIGERATED UNTIL ATTEMPTED USE. UPON OPENING BOX, VIALS WERE FOUND TO BE OVERLY TURBID. GRAM STAINS WERE PERFORMED. GRAM NEG RODS AND GRAM VARIABLE RODS SEEN. BOTH ARE NONVIABLE UPON SUBCULTURE. PRODUCT WAS DEEMED UNUSABLE FOR PATIENT TESTING.
IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN VIALS WERE FOUND OVERLY TURBID AND AFTER TESTING WAS DEEMED UNUSABLE FOR PATIENT TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBES RECEIVED 11/27 AND REFRIGERATED UNTIL ATTEMPTED USE. UPON OPENING BOX, VIALS WERE FOUND TO BE OVERLY TURBID. GRAM STAINS WERE PERFORMED. GRAM NEG RODS AND GRAM VARIABLE RODS SEEN. BOTH ARE NONVIABLE UPON SUBCULTURE. PRODUCT WAS DEEMED UNUSABLE FOR PATIENT TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1178629 | BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 221742 | 2279224 | 30382902217429 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |