BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 12292025 · Received August 6, 2021

    Report

    Report Number
    2647876-2021-00020
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 15, 2021
    Report Date
    September 2, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420222
    PMA / PMN Number
    K141810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER REPORTED BLOOD UNDER THE SENSOR. NEITHER PHOTOS NO RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO DUPLICATE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED WITH SATISFACTORY RESULTS. BLOOD BACKGROUND WAS PERFORMED WITH SATISFACTORY RESULTS. BATCH/SENSOR HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. SENSOR ADHESION SCRAPE TEST IS PERFORMED TO EACH SENSOR BATCH AS PART OF RELEASE CRITERIA. COMPLAINT IS UNCONFIRMED BASED RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW 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 AND PREVENTIVE ACTION (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 H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT SENSOR ADHESION OF BACTEC BOTTLE ACCORDING TO THE CUSTOMER'S REPORT, BLOOD FLOWED INTO THE MEDIA AT THE BOTTOM OF THE BOTTLE, WHICH CAUSED A FALSE POSITIVE."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT SENSOR ADHESION OF BACTEC BOTTLE ACCORDING TO THE CUSTOMER'S REPORT, BLOOD FLOWED INTO THE MEDIA AT THE BOTTOM OF THE BOTTLE, WHICH CAUSED A FALSE POSITIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185639 BD BACTEC PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442022 1020376 00382904420222

    Patients

    Seq Age Sex Outcome Treatment
    1