BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18156716 · Received November 16, 2023

    Report

    Report Number
    2647876-2023-00501
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    September 25, 2023
    Report Date
    December 7, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BATCH NO.: 3095914. CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. 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/RETURNED 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/RETURNED SAMPLES AND BATCHES HISTORY RECORD REVIEW RESULTS.

    Description of Event or Problem · 0

    REPORT 3 OF 3 IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A MOLECULAR FALSE POSITIVE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING MOLECULAR FALSE POSITIVES FOR PRODUCT 442023 TOTAL QUANTITY OF PRODUCT SHOWING DEFECT: 2 DIFFERENT PATIENT SPECIMENS. LOT NUMBER NOT AVAILABLE. PER QE 03-NOV-23, BATCH #3102722 AND #3095914 RETURNS RECEIVED AND PR UPDATED."

    Description of Event or Problem · 0

    REPORT 3 OF 3. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A MOLECULAR FALSE POSITIVE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING MOLECULAR FALSE POSITIVES FOR PRODUCT 442023. TOTAL QUANTITY OF PRODUCT SHOWING DEFECT: 2 DIFFERENT PATIENT SPECIMENS. LOT NUMBER NOT AVAILABLE. PER QE (B)(6) 23, BATCH #3102722 AND #3095914 RETURNS RECEIVED AND PR UPDATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153171 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3095914 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown