BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON TIP APPLICATOR

    MDR report key: 3203720 · Received June 25, 2013

    Report

    Report Number
    1417592-2013-00054
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON WAS PERFORMING AN ENDOSCOPIC CARPAL TUNNEL PROCEDURE. THE FACILITY REPORTED THAT HE WAS USING THE COTTON TIP APPLICATOR WHILE DISSECTING TISSUE INSIDE THE WRIST. THE COTTON CAME OFF THE APPLICATOR. THE SURGEON OPENED THE SURGICAL SITE AND RETRIEVED THE COTTON TIP. THE SAMPLE WAS RETURNED AND EVALUATED. THE RETURNED SAMPLE WAS RECEIVED AND THE COTTON TIP WAS NOT ATTACHED TO THE PLASTIC SHAFT OF THE APPLICATOR. THE PLASTIC SHAFT SHOWED NO SIGNS OF BREAKAGE OR DEFECTS THAT WOULD INDICATE A FAILURE WHICH COULD LEAD TO THE CUSTOMER REPORTED CONDITION. THE COTTON TIP WAS TIGHTLY WOUND AND SHOWED NO SIGNS OF MFG ERROR THAT WOULD CAUSE THE REPORTED CONDITION. THE COTTON TIP WAS FOUND TO BE FLATTENED AND ELONGATED IN SHAPE. THE FLAT AND ELONGATED COTTON TIP WOULD SUGGEST AN EXCESSIVE PRESSURE HAD BEEN PLACED ON THE DEVICE, AND WHEN PULLED BACK, THE ELONGATION OCCURRED. WE HAVE NOT HAD ANY OTHER SIMILAR INCIDENTS REPORTED TO US FOR THIS DEVICE. A ROOT CAUSE WAS NOT IDENTIFIED BUT WE CANNOT RULE OUT USER TECHNIQUE AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC SURGICAL PROCEDURE, THE COTTON TIP CAME OFF IN THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287752 COTTON TIP APPLICATOR KXG MEDLINE INDUSTRIES, INC. 505937670

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention