BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17990555 · Received October 23, 2023

    Report

    Report Number
    3008352382-2023-00266
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    September 16, 2023
    Report Date
    December 28, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442020. BATCH NO.: 3110965. 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 RECORDS 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 RECORDS REVIEW RESULTS. H3 OTHER TEXT : SEE H.10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) MOLECULAR FALSE POSITIVE FOR C. TROPICALIS OCCURRED. CONFIRMATORY TESTING GRAM STAIN GRAM POSITIVE COCCI IN PAIRS AND CHAINS AND CULTURE ONLY GREW STREP MITIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES SHE HAS MULTIPLE MOLECULAR FP FOR C. TROPICALIS GRAM STAIN:GRAM POSITIVE COCCI IN PAIRS AND CHAINS. CULTURE RESULTS: STREP MITIS. ACCESSION NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) MOLECULAR FALSE POSITIVE FOR C. TROPICALIS OCCURRED. CONFIRMATORY TESTING GRAM STAIN GRAM POSITIVE COCCI IN PAIRS AND CHAINS AND CULTURE ONLY GREW STREP MITIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES SHE HAS MULTIPLE MOLECULAR FP FOR C. TROPICALIS. GRAM STAIN:GRAM POSITIVE COCCI IN PAIRS AND CHAINS. CULTURE RESULTS: STREP MITIS. ACCESSION NUMBER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227042 BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3110965 00382904420208

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown