BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC SUBCULTURING/AEROBIC VENTING UNIT

    MDR report key: 11382360 · Received February 25, 2021

    Report

    Report Number
    1024879-2021-00152
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 1, 2021
    Report Date
    September 22, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JTA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE CUSTOMER COMPLAINT OF A BLOCKAGE/OBSTRUCTION CAUSING BLOOD TO NOT FLOW WITHIN THEIR VENT AEROBIC 50 EA (CAT. 249560, LOT 0093670), WAS CONFIRMED ON THE RETENTION SAMPLES THAT WERE INSPECTED. THE INSPECTION REVEALED A 50% REJECT RATE. THIS DEFECT WAS ORIGINALLY IDENTIFIED AND INVESTIGATED IN SEPTEMBER OF 2019. A SUPPLIER CORRECTIVE ACTION REQUEST WAS INITIATED TO BE COMPLETED AFTER THE SUPPLIER¿S INVESTIGATION. SCAR INVESTIGATION RESULTS: AN INVESTIGATION WAS CONDUCTED AT THE BD BROKEN BOW MANUFACTURING SITE. MATERIAL CLOGGING THE CANNULA IN RETURNED SAMPLES WAS REMOVED AND EXAMINED. THE MATERIAL WAS CLEAR VISCOUS LIQUID AND APPEARED TO BE SILICONE. THE CANNULA IS DIPPED IN SILICONE FOLLOWING THE ASSEMBLY PROCESS AT THE VENTUMATIC TURN TABLE. THE TABLE STATION FOLLOWING THE SILICONE DIP UTILIZES VACUUM TO REMOVE EXCESS SILICONE. THIS STATION WAS PARTIALLY CLOGGED ALLOWING EXCESS SILICONE TO REMAIN IN THE CANNULA. AS PART OF THE CORRECTIVE ACTION ON THE SCAR, A PREVENTATIVE MAINTENANCE ITEM WAS TO BE IMPLEMENTED TO REGU.LARLY CLEAR AND CLEAN THE VENTUMATIC STATION IN NOVEMBER OF 2019. DUE TO UNEXPECTED DELAYS, THE PREVENTATIVE MAINTENANCE WAS NOT IMPLEMENTED UNTIL SEPTEMBER OF 2020. LOT 0093670 WAS MANUFACTURED BEFORE THE PREVENTATIVE MAINTENANCE WAS IMPLEMENTED. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME AS THE CORRECTIVE ACTION HAS ALREADY TAKEN PLACE. BD QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR ANY BLOCKAGE ISSUES FOUND AFTER THE SEPTEMBER 2020 IMPLEMENTATION. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ SUBCULTURING/AEROBIC VENTING UNIT SAMPLE LEAKAGE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF EXPOSURE OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ SUBCULTURING/AEROBIC VENTING UNIT SAMPLE LEAKAGE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF EXPOSURE OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279700 BD BACTEC SUBCULTURING/AEROBIC VENTING UNIT MONITOR, MICROBIAL GROWTH JTA BECTON, DICKINSON & CO., (BD) 0093670

    Patients

    Seq Age Sex Outcome Treatment
    1