BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19363247 · Received May 21, 2024

    Report

    Report Number
    2647876-2024-00077
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    April 22, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 06-MAY-2024. INVESTIGATION SUMMARY: CATALOG 442023. BATCH NO. 3340577. CUSTOMER STATES THEY ARE RECEIVING STRANGE POSITIVE BLOOD CULTURES. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH THE BACTEC PRODUCT. A FALSE POSITIVE RESPONSE WAS NOT OBSERVED WHEN RETENTION/RETURNED SAMPLES WERE TESTED. 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 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. COMPLAINT IS UNCONFIRMED. 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

    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

    REPORT 2 OF 2. IT WAS REPORTED THAT WHEN USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS ONE CONTAMINATED BLOOD CULTURE BOTTLE. THE CONTAMINATED CULTURE GREW PANTOEA AGGLOMERANS, PSEUDOMONAS SPP, AND PSEUDOOMONAS STUZI. UNAWARE OF THE TREATMENT ADMINISTERED AT THIS TIME. NO ADVERSE IMPACT REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHEN USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS ONE CONTAMINATED BLOOD CULTURE BOTTLE. THE CONTAMINATED CULTURE GREW PANTOEA AGGLOMERANS, PSEUDOMONAS SPP, AND PSEUDOOMONAS STUZI. UNAWARE OF THE TREATMENT ADMINISTERED AT THIS TIME. NO ADVERSE IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155542 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3340577 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other