BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12832421 · Received November 17, 2021

    Report

    Report Number
    3008352382-2021-00190
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 21, 2021
    Report Date
    December 10, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER REPORTED BLOOD UNDER THE SENSOR AND FALSE POSITIVE RESULT. TWO PHOTOS SHOWED A 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 FOR SENSOR ADHESION DEFECT BASED ON PHOTOS RECEIVED. 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. CAPA#2882676 WAS INITIATED TO FURTHER INVESTIGATE THESE TYPES OF COMPLAINTS AND DETERMINE ANY APPROPRIATE ACTIONS TO REDUCE THEIR OCCURRENCE. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS. H3 OTHER TEXT : SEE H.10.

    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 WHILE TESTING WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE OCCURRED. CONFIRMATORY TESTING WAS PERFORMED USING A GRAM STAIN. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHORT DESCRIPTION: FALSE POSITIVE DUE TO THE PRESENCE OF BLOOD UNDER THE TEST DISC. WHERE DID THE INCIDENT OCCUR? DURING USE. DETAILED INCIDENT DESCRIPTION: A VIAL WAS FOUND TO BE POSITIVE AFTER 1 HOUR OF INCUBATION BUT NOT CONFIRMED BY GRAM STAIN. BLOOD WAS FOUND TO HAVE PASSED UNDER THE TEST DISC. PHOTOGRAPHS WERE SENT. WERE ANY ERRONEOUS RESULTS REPORTED? NO. IF SO - WERE ANY PATIENTS TREATED BASED ON THE ERRONEOUS RESULTS? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE OCCURRED. CONFIRMATORY TESTING WAS PERFORMED USING A GRAM STAIN. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHORT DESCRIPTION: FALSE POSITIVE DUE TO THE PRESENCE OF BLOOD UNDER THE TEST DISC. WHERE DID THE INCIDENT OCCUR ? DURING USE. DETAILED INCIDENT DESCRIPTION : A VIAL WAS FOUND TO BE POSITIVE AFTER 1 HOUR OF INCUBATION BUT NOT CONFIRMED BY GRAM STAIN. BLOOD WAS FOUND TO HAVE PASSED UNDER THE TEST DISC. PHOTOGRAPHS WERE SENT. WERE ANY ERRONEOUS RESULTS REPORTED? NO. IF SO - WERE ANY PATIENTS TREATED BASED ON THE ERRONEOUS RESULTS? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726365 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 1174481 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown