BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12771763 · Received November 8, 2021

    Report

    Report Number
    2647876-2021-00265
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 11, 2021
    Report Date
    November 16, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER REPORTED BLOOD UNDER THE SENSOR AND FALSE POSITIVE ISSUE. ONE PHOTO WAS RECEIVED WITH SENSOR ADHESION DEFECT. BD WAS UNABLE TO DUPLICATE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED WITH SATISFACTORY RESULTS. BATCH/SENSOR HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. BLOOD BACKGROUND WAS PERFORMED WITH SATISFACTORY RESULTS. 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 CONFIRMED BASED ON PHOTOS RECEIVED FOR SENSOR ADHESION. FALSE POSITIVE ISSUE WAS NOT CONFIRMED BASED ON RETENTION SAMPLES RESULTS. THE VISION SYSTEM IS CHALLENGED PRIOR EACH LOT. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. 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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WHILE USING BD BACTEC¿; PLUS AEROBIC/F CULTURE VIALS (PLASTIC) FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVES DUE TO BLOOD BETWEEN BOTTLE AND SENSOR. IN THE WEEKEND THE CUSTOMER SEES BLOOD FALSE POSITIVE SIGNALS, AND THERE IS BLOOD BETWEEN THE BOTTLE BOTTOM AND THE INDICATOR. IT SEEMS THAT THE SENSOR IS COMING OF THE BOTTLE BOTTOM. WHICH RESULTS IN FALSE POSITIVE SIGNALS. NUMBER OF BOTTLES INVOLVED IS REQUESTED, AS WELL AS SAMPLES BUT NOT CONFIRMED YET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿; PLUS AEROBIC/F CULTURE VIALS (PLASTIC) FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVES DUE TO BLOOD BETWEEN BOTTLE AND SENSOR. IN THE WEEKEND THE CUSTOMER SEES BLOOD FALSE POSITIVE SIGNALS, AND THERE IS BLOOD BETWEEN THE BOTTLE BOTTOM AND THE INDICATOR. IT SEEMS THAT THE SENSOR IS COMING OF THE BOTTLE BOTTOM. WHICH RESULTS IN POSITIVE SIGNALS. NUMBER OF BOTTLES INVOLVED IS REQUESTED, AS WELL AS SAMPLES BUT NOT CONFIRMED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666222 BD BACTEC¿; PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 1167274 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown