BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIPHOR ANTIMICROBIAL IRRIGATION

    MDR report key: 16475386 · Received March 2, 2023

    Report

    Report Number
    1423507-2023-00087
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 6, 2023
    Report Date
    February 24, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    FRO
    UDI-DI
    00382909101102
    PMA / PMN Number
    K221504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    02MAR2023: NO SAMPLES OR PHOTOS WERE AVAILABLE. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. IF SAMPLES, PHOTOS OR ADDITIONAL INFORMATION BECOME AVAILABLE, BD WILL RE-OPEN AND INVESTIGATE ACCORDINGLY. THE PRODUCTION RECORD REVIEW WAS NOT COMPLETED AS THE BATCH/LOT INFORMATION IS NOT AVAILABLE. NO FURTHER ACTIONS ARE REQUIRED. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED. SEE NARRATIVE BELOW

    Description of Event or Problem · 0

    MY KAISER FRESNO HAS REACHED OUT TO ME ABOUT A QR CODE MALFUNCTION ON THE BOXES OF 910110. THEY SAID THAT THE QR CODE SCANS INTO THEIR SYSTEM AS 910100. I ASKED IF THIS WAS DUE TO A MISTAKE ON THEIR END BUT THEY ARE SAYING IT IS OUR MISTAKE. I HAVE NEVER SEEN THIS BEFORE SO I WAS REACHING OUT TO SEE IF YOU HAVE SEEN THIS OR BEST WAY TO DIRECT THE CUSTOMER?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058658 SURGIPHOR ANTIMICROBIAL IRRIGATION SURGIPHOR ANTIMICROBIAL IRRIGATION FRO CAREFUSION, INC 910110 UNKNOWN 00382909101102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other