BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES

    MDR report key: 21979513 · Received May 7, 2025

    Report

    Report Number
    1119779-2025-00363
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 11, 2025
    Report Date
    July 16, 2025
    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

    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

    THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED PRIOR TO USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES THAT ONE (1) TUBE EXHIBITED BIOLOGICAL CONTAMINATION. IN ADDITION, EXCESS LABELS WERE OBSERVED ON TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. INVESTIGATION SUMMARY: THE BATCH HISTORY RECORD REVIEW FOR BATCH 4213645 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 LABELING PROCESS FOR MATERIAL 245122 INCLUDES LABEL RECONCILIATION WHERE THE TOTAL NUMBER OF LABELS ISSUED IS RECONCILED WITH THE TOTAL QUANTITY OF LABELS USED ON (CARTONS/BOTTLES/TUBES/ETC), USED IN THE BATCH HISTORY RECORD, REJECTED AND UNUSED. ANY DISCREPANCIES MUST BE WITHIN ALLOWABLE LIMITS SPECIFIED IN THE LABELING CONTROL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR WAS REVIEWED TO CONFIRM THE FOLLOWING: THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED AND THERE WERE OTHER COMPLAINTS ON BATCH 4213645. RETENTION SAMPLES (100) WERE INSPECTED. THERE WAS NO LABEL DEFECTS OBSERVED. FOR FURTHER INVESTIGATION, FIVE SAMPLES WERE INCUBATED AT 20-25 DEGREES CELSIUS AND 5 SAMPLES WERE INCUBATED AT 33-37 DEGREES CELSIUS. AT SEVEN DAYS, THERE WAS NO GROWTH OBSERVED. THREE PHOTOS OF BATCH 4213645 EXP 2026-01-28 SHOWING CONTAMINATED AND DOUBLE LABELED TUBES. NO RETURNS WERE RECEIVED FOR THIS BATCH. BATCH 4213645 CAN BE CONFIRMED FOR CONTAMINATION AND EXCESS LABELS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR THE LISTED DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES THAT ONE (1) TUBE EXHIBITED BIOLOGICAL CONTAMINATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES THAT ONE (1) TUBE EXHIBITED BIOLOGICAL CONTAMINATION. IN ADDITION, EXCESS LABELS WERE OBSERVED ON TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129397 BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4213645 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown