BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13981139 · Received April 1, 2022

    Report

    Report Number
    2647876-2022-00077
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 4, 2022
    Report Date
    March 28, 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
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). INVESTIGATION SUMMARY: CATALOG 442023, BATCH NO. 1160551. CUSTOMER REPORTED BLOOD UNDER THE SENSOR AND A FALSE POSITIVE RESULT. THREE PHOTOS WERE RECEIVED WITH SENSOR ADHESION DEFECT. RETURNED GOOD SAMPLES WERE NOT RECEIVED. 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 FOR THE FALSE POSITIVE CLAIM. A COMPLAINT HISTORY REVIEW WAS CONDUCTED, AND BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. NO ADDITIONAL TESTING IS REQUIRED AT THIS TIME. 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. COMPLAINT IF UNCONFIRMED FOR FALSE POSITIVE. 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) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY GRAM AND CULTURE TESTING WAS PERFORMED, AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS BOTTLE PROMPTED AS POSITIVE BUT WHEN THEY PROCEED WITH GRAM STAIN AND CULTURE, THE RESULT WAS NOS. WHEN THEY WANT TO RE-INCUBATE THE BOTTLE, ERROR KEEP PERSIST ON BACTEC FX. THE CUSTOMER THEN NOTICED THAT THERE IS PRESENCE OF BLOOD AT THE BOTTOM OF THE FLUORESCENT SENSOR DYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192021 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 1160551 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown