BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 18807211 · Received February 29, 2024

    Report

    Report Number
    1119779-2024-00156
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    January 30, 2024
    Report Date
    September 12, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    PMA / PMN Number
    K954932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). D4. MEDICAL DEVICE LOT # 3194852 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG # 245114. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN THERE WERE MULTIPLE PMA/510K NUMBERS. THE INFORMATION FOR EACH ADDITIONAL PMA/510K IS AS FOLLOWS: G.5. PMA / 510(K)#: K974883 H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: MEDICAL DEVICE BRAND NAME: BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT. MEDICAL DEVICE CATALOG #: 245124. DEVICE MANUFACTURE DATE: 13-JUL-2023. MEDICAL DEVICE EXPIRATION DATE: 05-JAN-2025. B.5. DESCRIBE EVENT OR PROBLEM : IT WAS REPORTED THAT PRIOR TO USE OF BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, A CONTAMINANT IN THE MEDIA WAS OBSERVED. NO PATIENT IMPACT REPORTED. INVESTIGATION SUMMARY: MGIT 960 SUPPLEMENT KIT BATCH 3194852 IS COMPOSED OF MGIT PANTA BATCH 3194841 AND MGIT 960 GROWTH SUPPLEMENT BATCH 3194843. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 3194852 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH 3194852. THE COMPONENTS OF KIT BATCH 3194852 WERE REVIEWED AND ALL BATCH HISTORY RECORDS WERE SATISFACTORY AT TIME OF RELEASE PER INTERNAL PROCEDURES. PERFORMANCE OF EACH KIT COMPONENT WAS SATISFACTORY PER PROCEDURES. RETENTION SAMPLES WERE INSPECTED FOR GROWTH SUPPLEMENT BATCH 3194843 (6 VIALS) AND PANTA BATCH 3194841 (10 VIALS). THERE WERE NO VISIBLE DEFECTS WITH EITHER COMPONENT. FOR FURTHER INVESTIGATION, TWO PANTA VIALS WERE RECONSTITUTED WITH TWO GROWTH SUPPLEMENT (15 ML EACH) VIALS AND TWO PANTA VIALS WERE EACH RECONSTITUTED WITH AUTOCLAVED WATER (15 ML EACH). THE TWO PANTA VIALS AND THE REMAINING MEDIA IN ONE GROWTH SUPPLEMENT VIAL WERE INCUBATED AT 20-25 DEGREES CELSIUS. ONE PANTA VIAL AND THE REMAINING MEDIA IN ONE GROWTH SUPPLEMENT VIAL WERE INCUBATED AT 33-37 DEGREE CELSIUS. AT SEVEN DAYS INCUBATION, NO GROWTH WAS OBSERVED IN ANY OF THE INCUBATED VIALS. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. BOTH PHOTOS SHOWED A PANTA VIAL WITH FLOATING MATERIAL IN THE RECONSTITUTED VIAL. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. WITHOUT BATCH VERIFICATION IN THE PHOTOS, THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE OF BD BBL¿ MGIT¿ PANTA¿ ANTIBIOTIC MIXTURE, LYOPHILIZED, A CONTAMINANT IN THE MEDIA WAS OBSERVED. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE OF BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, A CONTAMINANT IN THE MEDIA WAS OBSERVED. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498537 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 3194852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown