BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML

    MDR report key: 13114490 · Received December 29, 2021

    Report

    Report Number
    1119779-2021-02060
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 1, 2021
    Report Date
    May 12, 2022
    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

    H.6. INVESTIGATION: MATERIAL 245122 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 1191962 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. THE LABELING PROCESS FOR MATERIAL 245122 INCLUDES LABEL RECONCILIATION WHERE THE TOTAL NUMBER OF LABELS ISSUED IS RECONCILED WITH THE TOTAL QUANTITY OF LABELS APPLIED TO TUBES, USED IN THE BATCH HISTORY RECORD, REJECTED AND UNUSED. ANY DISCREPANCIES MUST BE WITHIN ALLOWABLE LIMITS SPECIFIED IN THE LABELING CONTROL PROCEDURE. THE LABEL RECONCILIATION FOR BATCH 1191962 DOES NOT SHOW AN EXCESS OF LABELS AFTER MANUFACTURING WHICH WOULD SUPPORT THE INCIDENCE OF A TUBE WITHOUT A LABEL. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS FOR EITHER DEFECT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1191962 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO CAP, OR TUBE DEFECTS WERE OBSERVED IN 100/100 RETENTION SAMPLES. ALL 100/100 RETENTION TUBES HAD A PROPERLY AFFIXED TUBE LABEL. ONE PHOTO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION: THE PHOTO SHOWS FOUR TUBES LAYING ON A COUNTER. THREE TUBES STILL HAVE THE CAP ON THE TUBE. ONE TUBE THE CAP IS MISSING. ALL FOUR TUBES ARE MISSING A LABEL. NO PRODUCT INFORMATION IS PRESENTED IN THE PHOTO. A PHOTO ALONE CANNOT CONFIRM A COMPLAINT. A PHOTO MUST HAVE PRODUCT INFORMATION SUCH AS BATCH NUMBER, OR A PRODUCT CARTON WHICH MUST SHOW THE PRODUCT LABEL SO THAT THE BATCH NUMBER AND PRODUCT INFORMATION IS PRESENTED. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR EITHER DEFECT. BD WILL CONTINUE TO TREND COMPLAINTS FOR CAP DEFECTS, LABELING, AND PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABELS WERE MISSING FROM BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML. THIS OCCURRED WITH 10 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE TUBE DOES NOT HAVE ANY LABELING STICKERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABELS WERE MISSING FROM BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML. THIS OCCURRED WITH 10 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE TUBE DOES NOT HAVE ANY LABELING STICKERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011757 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245122 1191962 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown