BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 17859250 · Received October 3, 2023

    Report

    Report Number
    3008352382-2023-00169
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    August 31, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    . INVESTIGATION SUMMARY: CATALOG: 442021 BATCH NO.: 3130610 & 3138060 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 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 HISTORY RECORD REVIEW RESULTS.

    Description of Event or Problem · 0

    REPORT 1 OF 3: IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) MOLECULAR FALSE POSITIVE OF C. TROPICALIS OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOLECULAR FP FOR C. TROPICALIS. LOT # 3130610: ON 8/31 1 PATIENT. 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? C. TROPICALIS AND(B)(6)31: LOT # 3130610 - GNB, KLEB PNEUMO. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) NOT C. TROPICALIS.

    Description of Event or Problem · 0

    REPORT 1 OF 3 IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) MOLECULAR FALSE POSITIVE OF C. TROPICALIS OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOLECULAR FP FOR C. TROPICALIS. LOT # 3130610: ON 8/31 1 PATIENT 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? C. TROPICALIS AND 8/31: LOT # 3130610 - GNB, KLEB PNEUMO 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) NOT C. TROPICALIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466973 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3130610 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown