BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 19354310 · Received May 20, 2024

    Report

    Report Number
    2647876-2024-00073
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 17, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY. CATALOG 442023. BATCH NO. 4032374. CUSTOMER REPORTED A FALSE POSITIVE DEFECT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH THE BACTEC PRODUCT. A FALSE POSITIVE RESPONSE WAS NOT OBSERVED WHEN RETENTION SAMPLES WERE TESTED. BATCH HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. USERS ARE CAUTIONED IN THE PACKAGE INSERT UNDER LIMITATION OF THE PROCEDURE: A GRAM-STAINED SMEAR FROM A CULTURE MEDIUM MAY CONTAIN SMALL NUMBERS OF NONVIABLE ORGANISMS DERIVED FROM MEDIA CONSTITUENTS, STAINING REAGENTS, IMMERSION OIL, GLASS SLIDES, AND SPECIMENS USED FOR INOCULATION. IN ADDITION, THE PATIENT SPECIMEN MAY CONTAIN ORGANISMS THAT WILL NOT GROW IN THE CULTURE MEDIUM OR IN MEDIA USED FOR SUBCULTURE. SUCH SPECIMENS SHOULD BE SUBCULTURE TO SPECIAL MEDIA AS APPROPRIATE. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. NO CORRECTIVES ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS.

    Additional Manufacturer Narrative · 0

    E.1 INITIAL REPORTER FACILITY NAME: (B)(6) . G5: PMA/510(K)#: K222591. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS ONE OCCURRENCE OF A MOLECULAR FALSE POSITIVE. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS ONE OCCURRENCE OF A MOLECULAR FALSE POSITIVE. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749855 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 4032374 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown