BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17752979 · Received September 15, 2023

    Report

    Report Number
    1119779-2023-00998
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 30, 2023
    Report Date
    November 27, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CATALOG: 442023. BATCH NO.: 3102712. 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 BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. NO CORRECTIVE ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS MOLECULAR FALSE POSITIVE BACTEC MEDIA. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THEY HAVE BEEN DETECTING MOLECULAR FALSE POSITIVES FOR C. TROPICALIS IN LOT#:3102712. THE BOTTLES GAVE A POSITIVE RESULT FOR STAPHYLOCOCCUS AUREUS. THEY WERE TESTED WITH GRAM STAIN AND PLATE GROWTH. NO C. TROPICALIS WAS DETECTED. CANDIDA ONLY CAME UP ON THE BIOFIRE. THU AUG 31 23:20:24 UTC 2023 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS MOLECULAR FALSE POSITIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS MOLECULAR FALSE POSITIVE BACTEC MEDIA. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THEY HAVE BEEN DETECTING MOLECULAR FALSE POSITIVES FOR C. TROPICALIS IN LOT#:3102712. THE BOTTLES GAVE A POSITIVE RESULT FOR STAPHYLOCOCCUS AUREUS. THEY WERE TESTED WITH GRAM STAIN AND PLATE GROWTH. NO C. TROPICALIS WAS DETECTED. CANDIDA ONLY CAME UP ON THE BIOFIRE. THURSDAY AUG 31 23:20:24 UTC 2023 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS MOLECULAR FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294434 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 3102712 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown