BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16523415 · Received March 10, 2023

    Report

    Report Number
    3008352382-2023-00022
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    March 1, 2023
    Report Date
    September 23, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420208
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN CORRECTED: D1: MEDICAL DEVICE BRAND NAME: BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) D2A: COMMON DEVICE NAME:SYSTEM, BLOOD CULTURING. D2B: MEDICAL DEVICE TYPE OR (PROCODE) MDB. D4 UDI: (B)(4). D4. MEDICAL DEVICE LOT#: 2284988. G5. PMA/510K INFO: K151866.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. 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 BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. NO TREND IDENTIFIED FOR BATCH. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS.

    Additional Manufacturer Narrative · 0

    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 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) RECEIVING FALSE POSITIVE OF C.TROPICALIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES MOLECULAR FP OF C. TROPICALIS WITH MULTIPLE LOT NUMBERS OF BLOOD CULTURE BOTTLES. ED VISIT FOR REDRAW

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) RECEIVING FALSE POSITIVE OF C.TROPICALIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES MOLECULAR FP OF C. TROPICALIS WITH MULTIPLE LOT NUMBERS OF BLOOD CULTURE BOTTLES. ED VISIT FOR REDRAW

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) RECEIVING FALSE POSITIVE OF C.TROPICALIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES MOLECULAR FP OF C. TROPICALIS WITH MULTIPLE LOT NUMBERS OF BLOOD CULTURE BOTTLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921855 BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442021 2284988 00382904420208

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female