BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18127767 · Received November 13, 2023

    Report

    Report Number
    2647876-2023-00469
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    October 21, 2023
    Report Date
    December 18, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420208
    PMA / PMN Number
    K151866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. 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 SUMMARY: CATALOG 442020. BATCH NO. 3123425. CUSTOMER REPORTED A FALSE NEGATIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE CUSTOMER¿S EXPERIENCE WITH BACTEC PRODUCT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN TESTED FOR MICROBIAL INSTRUMENT DETECTION AS PER QUALITY PROCEDURES. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT (I.E. FALSE NEGATIVE). MICROBIAL INSTRUMENT DETECTION INDICATED THAT THE PRODUCT IS PERFORMING AS EXPECTED. 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 BASED ON RETENTION SAMPLES AND BATCH RECORD REVIEW RESULTS. NO CORRECTIVE 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 INVESTIGATIONAL PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), A FALSE NEGATIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), A FALSE NEGATIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988595 BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3123425 00382904420208

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown