BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18643824 · Received February 5, 2024

    Report

    Report Number
    2647876-2024-00029
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 12, 2024
    Report Date
    March 13, 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
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442023; BATCH NO.: 3110054. CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED, AND BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. NO TREND IDENTIFIED FOR BATCH. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS.

    Additional Manufacturer Narrative · 0

    G.5 PMA / 510(K)# K113558, K222591. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS A FALSE POSITIVE FOR CANDIA TROPICAL ON PANEL BCID2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS A FALSE POSITIVE FOR CANDIDA TROPICALIS ON PANEL BCID2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906300 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3110054 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown