BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML

Report

Report Number: 1119779-2023-00243
Event Type: Malfunction
Date Received: March 8, 2023
Date of Event: March 1, 2023
Report Date: April 20, 2023
Manufacturer: BECTON, DICKINSON & CO. (SPARKS)
Product Code: MDB
UDI-DI: 30382902451229
PMA / PMN Number: K974883
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

MEDICAL DEVICE LOT #: 2089910. MEDICAL DEVICE EXPIRATION DATE: 2023-09-24. DEVICE MANUFACTURE DATE: 2022-03-30. MEDICAL DEVICE LOT #: 2068227. MEDICAL DEVICE EXPIRATION DATE: 2023-09-03. DEVICE MANUFACTURE DATE: 2022-03-09. MEDICAL DEVICE LOT #: 0203858. MEDICAL DEVICE EXPIRATION DATE: 2022-01-19. DEVICE MANUFACTURE DATE: 2020-07-21. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative · 0

A NEW LOT NUMBER HAS BEEN ADDED TO THE PR. D4. MEDICAL DEVICE LOT #, D4. MEDICAL DEVICE EXPIRATION DATE, H4. DEVICE MANUFACTURE DATEHAVE BEEN UPDATED TO REFLEX THE NEW LOT. MATERIAL 245122 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 0231577. THE BATCH HISTORY RECORD REVIEW FOR BATCH 0231577 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, LABELING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. CHECKS FOR FILL VOLUME WERE COMPLETE AND WITHIN SPECIFICATIONS PER PROCEDURES. THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR LABELING OR BROKEN/CRACKED TUBES. ONE OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH FOR FILL VOLUME. RETENTION SAMPLES FROM BATCH 0231577 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO FILL VOLUME DEFECTS WERE OBSERVED IN 100/100 RETENTION TUBES. FOR FURTHER INVESTIGATION, THE FILL VOLUME WAS MEASURED USING A FILL VOLUME MEASURING TOOL FOR ALL 100 RETENTION TUBES. THERE WAS NO EVIDENCE OF ANY TUBE HAVING OVER THE ACCEPTABLE FILL VOLUME OR UNDER THE ACCEPTABLE FILL VOLUME FOR MATERIAL 245122. NO BROKEN/CRACKED CAPS WERE OBSERVED IN 100/100 RETENTION SAMPLES. ALL 100/100 RETENTION TUBES HAD PROPERLY AFFIXED AND LEGIBLE LABELS WITH A SCANNABLE BARCODE LABEL. BATCH 2068227. THE BATCH HISTORY RECORD REVIEW FOR BATCH 2068227 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, LABELING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. CHECKS FOR FILL VOLUME WERE COMPLETE AND WITHIN SPECIFICATIONS PER PROCEDURES. THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR EITHER DEFECT. RETENTION SAMPLES FROM BATCH 2068227 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO FILL VOLUME DEFECTS WERE OBSERVED IN 100/100 RETENTION TUBES. FOR FURTHER INVESTIGATION, THE FILL VOLUME WAS MEASURED USING A FILL VOLUME MEASURING TOOL FOR ALL 100 RETENTION TUBES. THERE WAS NO EVIDENCE OF ANY TUBE HAVING OVER THE ACCEPTABLE FILL VOLUME OR UNDER THE ACCEPTABLE FILL VOLUME FOR MATERIAL 245122. NO BROKEN/CRACKED CAPS WERE OBSERVED IN 100/100 RETENTION SAMPLES. ALL 100/100 RETENTION TUBES HAD PROPERLY AFFIXED AND LEGIBLE LABELS WITH A SCANNABLE BARCODE LABEL. BATCH 2089910. THE BATCH HISTORY RECORD REVIEW FOR BATCH 2089910 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, LABELING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. CHECKS FOR FILL VOLUME WERE COMPLETE AND WITHIN SPECIFICATIONS PER PROCEDURES. THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR EITHER DEFECT. RETENTION SAMPLES FROM BATCH 2089910 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO FILL VOLUME DEFECTS WERE OBSERVED IN 100/100 RETENTION TUBES. FOR FURTHER INVESTIGATION, THE FILL VOLUME WAS MEASURED USING A FILL VOLUME MEASURING TOOL FOR ALL 100 RETENTION TUBES. THERE WAS NO EVIDENCE OF ANY TUBE HAVING OVER THE ACCEPTABLE FILL VOLUME OR UNDER THE ACCEPTABLE FILL VOLUME FOR MATERIAL 245122. NO BROKEN/CRACKED CAPS WERE OBSERVED IN 100/100 RETENTION SAMPLES. ALL 100/100 RETENTION TUBES HAD PROPERLY AFFIXED AND LEGIBLE LABELS WITH A SCANNABLE BARCODE LABEL. BATCH 0203858. THE BATCH HISTORY RECORD REVIEW FOR BATCH 0203858 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, LABELING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. CHECKS FOR FILL VOLUME WERE COMPLETE AND WITHIN SPECIFICATIONS PER PROCEDURES. THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR EITHER DEFECT. RETENTION SAMPLES FROM BATCH 0203858 (100 TUBES) WERE NOT AVAILABLE FOR INSPECTION. BATCH 1063895. THE BATCH HISTORY RECORD REVIEW FOR BATCH 1063895 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, TORQUEING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. CHECKS FOR FILL VOLUME WERE COMPLETE AND WITHIN SPECIFICATIONS PER PROCEDURES AND CHECKS FOR TORQUE CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND THERE ARE NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR FILL VOLUME. RETENTION SAMPLES FROM BATCH 1063895 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO FILL VOLUME DEFECTS WERE OBSERVED IN 100/100 RETENTION SAMPLES. ALL 100/100 RETENTION TUBES WERE MEASURED USING A FILL VOLUME MEASURING TOOL. ALL 100/100 RETENTION TUBES MEASURED AT THE ACCEPTABLE FILL VOLUME MEASURING LINE. THERE WAS NO EVIDENCE OF ANY TUBE HAVING OVER THE ACCEPTABLE FILL VOLUME OR UNDER THE ACCEPTABLE FILL VOLUME FOR MATERIAL 245122. FIVE PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS THREE TUBES HELD IN THE FRONT OF SOME 7ML MGIT TUBES IN THE BACKGROUND. ONE TUBE IS FROM BATCH 2089910, AND ONE TUBE IS FROM BATCH 2068227. ONE TUBE IS MISSING A LABEL. ALSO NOTED A LABEL IS PEELING OFF A TUBE FOR A TUBE IN THE BACKGROUND. THE FILL VOLUME APPEARS LOWER THAN THE EXPECTED AMOUNT IN THE TUBE WITHOUT A LABEL. THE CAPS APPEAR TO BE CROOKED ON ALL THREE TUBES. THE CAPS ON THE TUBES FROM BATCH 2089910 AND BATCH 2068227 APPEAR TO BE CRACKED/CHIPPED/BROKEN. THE SECOND PHOTO SHOWS ONE TUBE WITH A DAMAGED CAP. THE CAP APPEARS CROOKED AND SCRAPED POSSIBLY FROM THE TORQUEING PROCESS. THE FILL VOLUME IN THIS PHOTO APPEARS TO BE LOWER THAN EXPECTED. THE THIRD PHOTO SHOWS A PARTIAL TUBE FROM BATCH 0203858. THE LABEL APPEARS TO BE PEELING OFF THE TUBE. THE FOURTH PHOTO SHOWS A PARTIAL TUBE FROM BATCH 0231577. THE CAP APPEARS TO BE CRACKED/BROKEN/CHIPPED. THE MEDIA FILL APPEARS TO BE AS EXPECTED. THE LAST PHOTO SHOWS FOUR TUBES IN A TUBE RACK FROM BATCH 1063895. THE LABELS ON ONE TUBE APPEARS HAVE MULTIPLE LABELS. TWO TUBES THE LABELS APPEAR TO HAVE PEELED OFF THE TUBE. THE FILL VOLUME DOES APPEAR LOWER THAN EXPECTED IN ONE OF THE TUBES. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE COMPLAINT CAN BE CONFIRMED BY THE PHOTOS RECEIVED FOR NO LABELS FOR BATCHES 2068227, 2089910, 0203858, AND BATCH 0231577. THE COMPLAINT CAN BE CONFIRMED FOR A BROKEN/CHIPPED/CRACKED CAPS FOR BATCH 0231577, 2089910, AND 2068227 BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS RECEIVED. THE COMPLAINT CANNOT BE CONFIRMED FOR A CAP DEFECT FOR BATCH 0203858 BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS RECEIVED. THE COMPLAINT CAN BE CONFIRMED FOR A LOW FILL VOLUME FOR BATCHES 0231577, 0203858, 2089910, 2068227, AND 1063895 BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS RECEIVED. NO COMPLAINT TRENDS FOR THESE DEFECTS HAVE BEEN IDENTIFIED FOR THESE PRODUCT ;NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR FILL VOLUME, MISSING LABELS, AND CAP DEFECTS. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHILE USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THAT THERE WAS A MISSING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEWLY OPENED CULTURE TUBE IS NOT LABELLED. [2 MARCH 2023] ¿ RCC REVIEWED THE SUPPORTING EVIDENCE AND FOUND THAT SOME OF THE TUBES IS NOT LABELLED TO INDICATE ITS CONTENT.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHILE USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THAT THERE WAS A MISSING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEWLY OPENED CULTURE TUBE IS NOT LABELLED. [2 MARCH 2023] ¿ RCC REVIEWED THE SUPPORTING EVIDENCE AND FOUND THAT SOME OF THE TUBES IS NOT LABELLED TO INDICATE ITS CONTENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
121621	BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML	SYSTEM, BLOOD CULTURING	MDB	BECTON, DICKINSON & CO. (SPARKS)	245122	1063895	30382902451229

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown