BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14306903 · Received May 6, 2022

    Report

    Report Number
    2647876-2022-00128
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 11, 2022
    Report Date
    June 2, 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

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER REPORTED A SENSOR ADHESION DEFECT AND A FALSE POSITIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS NOT ABLE TO PERFORM AN INVESTIGATION TO THE RETENTION SAMPLE SINCE NEITHER BATCH NUMBER NOR RETURNED GOODS SAMPLES WERE AVAILABLE. A COMPLAINT HISTORY REVIEW CANNOT BE CONDUCTED RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE SINCE BATCH NUMBER IS UNKNOWN. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. COMPLAINT IS UNCONFIRMED. 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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) PRODUCED A FALSE POSITIVE. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "A FALSE POSITIVE WAS REPORTED AT 11:30AM."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) PRODUCED A FALSE POSITIVE. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "A FALSE POSITIVE WAS REPORTED AT 11:30AM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001099 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 UNKNOWN 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown