BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA MEDIUM

    MDR report key: 17981520 · Received October 20, 2023

    Report

    Report Number
    1119779-2023-01160
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    October 5, 2023
    Report Date
    January 16, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    30382902451151
    PMA / PMN Number
    K021582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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

    H.6. 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 BATCH HISTORY RECORD REVIEW FOR BATCH 3040101 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, TORQUING, 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR MISSING LABEL. RETENTION SAMPLES FROM BATCH 3040101 (79 TUBES) WERE AVAILABLE FOR INSPECTION. ALL RETENTION TUBES WERE INSPECTED AND ALL 79 RETENTION SAMPLES WERE PROPERLY LABELED. ONE (1) PHOTO WAS RECEIVED FOR REVIEW FOR THIS COMPLAINT. THE PHOTO SHOWS A SINGLE UNLABELED TUBE. THERE IS NO BATCH INFORMATION IN THIS PHOTO. NO RETURNS WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT CANNOT BE CONFIRMED. THERE IS NO BATCH INFORMATION PRESENT IN ANY OF THE PHOTOS SUBMITTED, AND NO OTHER PRODUCT LABELS WERE VISIBLE FOR BATCH VERIFICATION. WITHOUT BATCH VERIFICATION, THE PHOTOS CANNOT CONFIRM THE COMPLAINT. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE IDENTIFIED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BACTEC¿ MGIT¿ 960 PZA MEDIUM A LABEL WAS MISSING FROM THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED THERE WASN¿T A LABEL ON THE PZA MEDIUM TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BACTEC¿ MGIT¿ 960 PZA MEDIUM A LABEL WAS MISSING FROM THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED THERE WASN¿T A LABEL ON THE PZA MEDIUM TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272277 BD BACTEC¿ MGIT¿ 960 PZA MEDIUM SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) 3040101 30382902451151

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown