BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAP BOUFFANT SPUNBONDED BLUE

    MDR report key: 2699856 · Received August 15, 2012

    Report

    Report Number
    1423537-2012-00030
    Event Type
    Injury
    Date Received
    August 15, 2012
    Date of Event
    July 6, 2012
    Report Date
    August 15, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FYF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE THE SAMPLE OR THE LOT NUMBER, BUT DID PROVIDE A PHOTO OF THE NEEDLE. WITHOUT THE LOT NUMBER OR SAMPLE, WE WERE NOT ABLE TO CONFIRM THE REPORTED INCIDENT. HISTORICAL TRENDING WAS DONE. A REVIEW OF THE PHOTO OF THE NEEDLE (PROVIDED BY THE CUSTOMER) SUGGESTED THE REPORTED NEEDLE WAS A MEDICAL NEEDLE. THESE NEEDLES WERE NOT USED DURING MANUFACTURING, AND WOULD NOT HAVE ORIGINATED FROM OUR MANUFACTURING FACILITY FOR THE BOUFFANT CAP. WE WILL CONTINUE TO MONITOR FOR TRENDS OF THIS NATURE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THERE WAS A NEEDLE EMBEDDED IN THE CAP, AND THEY PUT THE CAP ON THE PATIENT WITHOUT KNOWING. THE PATIENT THEN RECEIVED MULTIPLE LACERATIONS AS A RESULT OF IT BEING ON THEIR HEAD. THE AREA WAS WASHED AND A BANDAGE APPLIED. A NEEDLE STICK SCREEN WAS DONE AND REPORTED TO BE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAP BOUFFANT SPUNBONDED BLUE CAP, SURGICAL FYF CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other