BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14342427 · Received May 9, 2022

    Report

    Report Number
    2647876-2022-00133
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 26, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 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

    H6: INVESTIGATION SUMMARY CUSTOMER REPORTED A SENSOR ADHESION DEFECT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. RETENTION SAMPLES COULD NOT BE VISUALLY INSPECTED/ TESTED FOR REPORTED DEFECT. BATCH HISTORY RECORD REVIEW WAS USED FOR THIS INVESTIGATION. BATCH/SENSOR HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. 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. SENSOR ADHESION SCRAPE TEST IS PERFORMED TO EACH SENSOR BATCH AS PART OF RELEASE CRITERIA. COMPLAINT IS UNCONFIRMED BASED ON BATCH HISTORY RECORD REVIEW. CORRECTIVE ACTIONS PREVENTIVE ACTIONS (CAPA) 2882676 WAS INITIATED TO FURTHER INVESTIGATE THESE TYPES OF COMPLAINTS AND DETERMINE ANY APPROPRIATE ACTIONS TO REDUCE THEIR OCCURRENCE. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) RESULTED IN FALSE POSITIVES. THIS IS A REPORT OF 1 OCCURRENCE. RESULTS WERE NOT REPORTED TO CLINICIAN OR PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT SENSOR ADHESION OF A BACTEC BOTTLE. ACCORDING TO THE CUSTOMER'S INFORMATION, BLOOD FLOWED INTO ABOUT 70% OF THE SENSOR AT THE BOTTOM OF THE BOTTLE, WHICH CAUSED A FALSE POSITIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) RESULTED IN FALSE POSITIVES. THIS IS A REPORT OF 1 OCCURRENCE. RESULTS WERE NOT REPORTED TO CLINICIAN OR PATIENT . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT SENSOR ADHESION OF A BACTEC BOTTLE. ACCORDING TO THE CUSTOMER'S INFORMATION, BLOOD FLOWED INTO ABOUT 70% OF THE SENSOR AT THE BOTTOM OF THE BOTTLE, WHICH CAUSED A FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394029 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 1252583 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown