BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA MEDIUM

    MDR report key: 20022704 · Received August 21, 2024

    Report

    Report Number
    1119779-2024-00621
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 16, 2024
    Report Date
    January 7, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    30382902451151
    PMA / PMN Number
    K021582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION FOR THE MULTIPLE LOTS ARE AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 3292159, D.4. MEDICAL DEVICE EXPIRATION DATE: 11-APR-2025, H.4. DEVICE MANUFACTURE DATE: 19-OCT-2023. D.4. MEDICAL DEVICE LOT #: 3306754, D.4. MEDICAL DEVICE EXPIRATION DATE: 02-MAY-2025, H.4. DEVICE MANUFACTURE DATE: 02-NOV-2023. 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

    INVESTIGATION SUMMARY: MATERIAL 245115 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 BD MGIT PZA TESTING SYSTEM CONSISTS OF MGIT PZA 7ML TUBES (MATERIAL 245115) AND THE MGIT PZA DRUG KIT (MATERIAL 245128). THE MGIT PZA DRUG KIT CONSISTS OF LYOPHILIZED PZA DRUG AND LIQUID PZA SUPPLEMENT COMPONENTS. THE PZA DRUG, PZA SUPPLEMENT AND PZA 7ML TUBES ARE USED TOGETHER TO PERFORM PZA TESTING IN THE BD BACTEC MGIT INSTRUMENTS. A COMPLAINT TREND FOR PERFORMANCE WAS IDENTIFIED INVOLVING 245115 AND 245128 MGIT PZA KIT BATCHES. BD HAS INITIATED A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) TO FORMALLY INVESTIGATE THE PERFORMANCE ISSUE. THE INVESTIGATION HAS RULED OUT MGIT PZA 7ML TUBES (MATERIAL 245115) AS THE CAUSE OF INCREASED, INTERMITTENT FALSE RESISTANCE RESULTS OBSERVED. THE BATCH HISTORY RECORD REVIEW IS SATISFACTORY FOR THE INCIDENT LOTS. RETENTION SAMPLES WERE TESTED PER THE STANDARD PERFORMANCE PROCEDURE WHICH IS ALSO DESCRIBED IN THE IFU (INSTRUCTIONS FOR USE, AVAILABLE ON BD.COM/E-LABELING). RETENTION SAMPLE TESTING CONDUCTED FOR COMPLAINT INVESTIGATIONS HAVE NOT REPLICATED THE REPORTED DEFECT. RETENTION SAMPLES WERE REVIEWED FOR FILL VOLUME. ALL RETENTIONS FOR BATCHES 3306754 AND 3292159 WERE APPROPRIATELY FILLED. BECAUSE THE MGIT PZA 7ML TUBES WERE RULED OUT BY THE CAPA INVESTIGATION AND RETENTION SAMPLE TESTING HAS NOT REPLICATED THE FALSE RESISTANCE, THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. TWELVE PHOTOS WERE AVAILABLE FOR REVIEW FOR THIS COMPLAINT. THERE WERE 6 PHOTOS WHICH SHOWED VARYING FILL VOLUMES OF TUBES FROM BATCHES 3306754 WITH EXPIRATION 2025-05-02 AND 3292159 WITH EXPIRATION 2025-04-11. THE REMAINING PHOTOS SHOWED TESTING DATA. OBSERVATIONS AND CONCLUSIONS ABOUT PERFORMANCE CANNOT BE MADE FROM TEST DATA PROVIDED. THIS COMPLAINT CAN BE CONFIRMED FOR FILL VOLUME. BD WILL CONTINUE TO TREND COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, AN UNSPECIFIED NUMBER OF TUBES WERE OBSERVED TO HAVE FILL VOLUME DIFFERENCES. UPON TESTING WITH THESE AFFECTED TUBES, THE CUSTOMER OBTAINED VARYING PZA RESULTS INCLUDING RESISTANCE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, AN UNSPECIFIED NUMBER OF TUBES WERE OBSERVED TO HAVE FILL VOLUME DIFFERENCES. UPON TESTING WITH THESE AFFECTED TUBES, THE CUSTOMER OBTAINED VARYING PZA RESULTS INCLUDING RESISTANCE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014752 BD BACTEC¿ MGIT¿ 960 PZA MEDIUM SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) SEE H.11 30382902451151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown