BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLV EXAM PF THIN NITRILE FINGER TEX MD

    MDR report key: 2945558 · Received February 6, 2013

    Report

    Report Number
    1423537-2013-00006
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 6, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE INVOLVED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION, BUT A PHOTO OF THE BLADE WAS REVIEWED AS PART OF THE INVESTIGATION AND IT WAS DETERMINED THAT THIS TYPE OF BLADE IS NOT USED ANYWHERE AT THE MANUFACTURING FACILITY. THIS TYPE OF BLADE MOST LIKELY CAME FROM THE PACKAGING MATERIAL SUPPLIER AND WAS NOT DETECTED DURING INCOMING INSPECTION. A COMPLETE REVIEW OF THE MANUFACTURING HISTORY WAS CONDUCTED. THE PACKAGING PROCESS WAS CONTROLLED WITHIN SPECIFICATION DURING PACKAGING OPERATION. THE INSPECTION DATA FOR THIS PRODUCT CODE WAS REVIEWED AND NO OTHER REPORTS HAVE BEEN REPORTED FOR THIS TYPE OF FAILURE. THE PACKAGING SUPPLIER HAS BEEN NOTIFIED OF THIS REPORT AND HAS TAKEN CORRECTIVE ACTION TO PREVENT RECURRENCE OF THIS TYPE OF REPORT. INCOMING INSPECTION PROCESS HAS BEEN TIGHTENED AT THE GLOVE MANUFACTURING SITE IN ORDER TO PREVENT AND DETECT THIS TYPE OF REPORT IN THE FUTURE.

    Description of Event or Problem · 1

    (B)(6) INFORMED CARDINAL HEALTH THAT ONE OF THEIR ASSOCIATES IN THE DIETARY DEPARTMENT CUT HER FINGER (B)(6) ON A RUSTED BLADE THAT WAS LEFT IN A CASE OF NON-STERILE GLOVES # (B)(4), LOT #8L12K059. THE EMPLOYEE WAS SENT TO THE EMERGENCY DEPARTMENT FOR WOUND REPAIR, ANTIBIOTICS ON SITE, A PRESCRIPTION FOR A COURSE OF ANTIBIOTICS AND A DRESSING. THE EMPLOYEE IS DOING FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50523 GLV EXAM PF THIN NITRILE FINGER TEX MD EXAMINATION GLOVE LZA CARDINAL HEALTH 88TN03M 8L12K059

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other