BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18266252 · Received December 5, 2023

    Report

    Report Number
    3008352382-2023-00311
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    October 9, 2023
    Report Date
    January 16, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY CATALOG: 442023 BATCH NO.: 3110054 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE PMA/510K NUMBERS. THE INFORMATION FOR EACH ADDITIONAL PMA/510K IS AS FOLLOWS: G.5. PMA / 510(K)#: K222591. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT SAMPLE IN BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) GAVE A MOLECULAR FALSE POSITIVE RESULT. PATIENT #6: (B)(6) 2023 SEQUENCE #: 449293046500 BOTTLE LOT #: 3110054 BACTEC SN: (B)(6) BIOFIRE BCID2, CAT # RFIT-ASY-0147, LOT # 1980823 BIOFIRE WAS A DUAL POSITIVE - E. COLI, C. TROPICALIS PRELIM CULTURE RESULT: GRAM NEGATIVE ROD RESEMBLING E. COLI GRAM STAIN: GRAM NEGATIVE RODS NO ERRONEOUS RESULTS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT SAMPLE IN BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) GAVE A MOLECULAR FALSE POSITIVE RESULT. PATIENT (B)(6): (B)(6) 2023. SEQUENCE #: (B)(6). BOTTLE LOT #: 3110054. BACTEC SN: (B)(6). BIOFIRE BCID2, CAT # RFIT-ASY-0147, LOT # 1980823. BIOFIRE WAS A DUAL POSITIVE - E. COLI, C. TROPICALIS. PRELIM CULTURE RESULT: GRAM NEGATIVE ROD RESEMBLING E. COLI. GRAM STAIN: GRAM NEGATIVE RODS. NO ERRONEOUS RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064408 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3110054 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown