BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP PREP SKIN TRAY

    MDR report key: 10852891 · Received November 17, 2020

    Report

    Report Number
    3004932373-2020-00127
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 26, 2020
    Report Date
    November 18, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    OJU
    UDI-DI
    10885403184475
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION IT WAS OBSERVED THAT THERE WAS A SUBSTANCE ON THE FINGERS WHICH COULD HAVE HAPPENED BECAUSE THE GLOVES HAD HOLES IN THEM; THEREFORE, THE INCIDENT COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE INVESTIGATION, THE ROOT CAUSE COULD BE THE MATERIAL OF THE GLOVES. THE SUPPLIER OF THE GLOVES WAS MADE AWARE OF THE ISSUE. H3 OTHER TEXT : NO DEVICE RETURNED. PLEASE SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GLOVE HAS HOLES IN A FINGER AND THUMB.

    Additional Manufacturer Narrative · 1

    PR (B)(4) INITIAL MDR. A FOLLOW UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GLOVE HAS HOLES IN A FINGER AND THUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317596 IP PREP SKIN TRAY SKIN SCRUB TRAY OJU CAREFUSION, INC 4468 0004123773 10885403184475

    Patients

    Seq Age Sex Outcome Treatment
    1 Other