BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 12674555 · Received October 21, 2021

    Report

    Report Number
    1119779-2021-01693
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 1, 2021
    Report Date
    May 10, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY. MGIT 960 GROWTH SUPPLEMENT BATCH NUMBER 0240947 WAS PROVIDED FOR INVESTIGATION OF THIS COMPLAINT. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 GROWTH SUPPLEMENT BATCH 0240947 WAS SATISFACTORY PER INTERNAL PROCEDURE. FILLING, CAPPING, AND CRIMPING PROCESSES WERE WITHIN SPECIFICATIONS. IN-PROCESS CHECKS FOR FILL VOLUME PERFORMED AT DESIGNATED INTERVALS PER SOP WERE SATISFACTORY. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTION SAMPLES FROM BATCH 0240947 (10 VIALS) WERE AVAILABLE FOR INSPECTION. NO CRIMP, VIAL OR MEDIA DEFECTS WERE OBSERVED IN 8/8 RETENTION VIALS. NO EVIDENCE OF CONTAMINATION WAS FOUND IN 8/8 RETENTION SAMPLES. FOR FURTHER INVESTIGATION TWO RETENTION VIALS WERE INCUBATED. ONE VIAL WAS PLACED INTO 33¿37-DEGREE CELSIUS INCUBATION, AND ONE RETENTION VIAL WAS PLACE INTO 20¿25-DEGREE CELSIUS INCUBATION. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED. BATCH 0128440. MGIT 960 GROWTH SUPPLEMENT BATCH NUMBER 0128440 WAS PROVIDED FOR INVESTIGATION OF THIS COMPLAINT. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 GROWTH SUPPLEMENT BATCH 0128440 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING THE MANUFACTURING AND INSPECTION. FILLING, CAPPING, AND CRIMPING PROCESSES WERE WITHIN SPECIFICATIONS. IN-PROCESS CHECKS FOR FILL VOLUME PERFORMED AT DESIGNATED INTERVALS PER SOP WERE SATISFACTORY. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTION SAMPLES FROM BATCH 0128440 WERE NOT AVAILABLE FOR INSPECTION. THIS BATCH NUMBER HAS EXPIRED. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS ONE VIAL FROM BATCH 0240947. THE VIAL IS STILL CRIMP CAPPED AND THE FLAP ON THE CRIMP CAP DOES APPEAR TO BE FLIPPED UP SLIGHTLY. THE MEDIA IN THE VIAL DOES APPEAR TO BE CONTAMINATED. THE SECOND PHOTO SHOWS ONE VIAL FROM BATCH 0128440. THE CRIMP CAP HAS BEEN REMOVED. THE VIAL IS COMPLETELY EMPTY. CUSTOMER DID NOT PROVIDE A KIT BATCH NUMBER OR RETURNS FOR THIS COMPLAINT INVESTIGATION. TRENDING WAS DONE ON THE APPROPRIATE DATABASES FOR BACTEC MGIT 960 SUPPLEMENT (MATERIAL 245124) AND THE PROBABLE KIT BATCH WAS FOUND FOR BOTH SUPPLEMENT VIALS. NO QUALITY NOTIFICATIONS HAVE BEEN TAKEN ON EITHER OF THE KIT BATCHES. THERE ARE NO TRENDS FOR THE PROBABLE KIT BATCHES IN THE LAST 12 MONTHS. THE PHOTOS ARE NOTED AND ACKNOWLEDGED FOR THE ISSUES OBSERVED, HOWEVER, A KIT BATCH IS NEEDED TO CONFIRM A COMPLAINT FOR A DEFECT IN A KIT BATCH FOR MATERIAL 245124. BD WILL CONTINUE TO TREND COMPLAINTS FOR THESE ISSUES. THIS COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0240947 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT WAS CONTAMINATED AND GROWING BACTERIA UPON OPENING PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN CUSTOMER OPEN THE PACKAGE, ONE WAS CONTAMINATED GROWING BACTERIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT WAS CONTAMINATED AND GROWING BACTERIA UPON OPENING PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): WHEN CUSTOMER OPEN THE PACKAGE, ONE WAS CONTAMINATED GROWING BACTERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568236 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245124 0240947 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown