BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    MDR report key: 4919803 · Received July 16, 2015

    Report

    Report Number
    1423537-2015-00050
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    JIANERKANG MEDICAL DRESSING
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A THOROUGH INVESTIGATION INTO THE REPORTED ISSUE WAS CONDUCTED. WHILE A SAMPLE OR A LOT NUMBER WERE NOT PROVIDED FOR EVALUATION; OR TOWELS ARE MADE OF COTTON, LINT IS INHERENT. THE PRODUCT IS INTENDED TO BE USED AS A PROTECTIVE PATIENT COVERING SUCH AS TO ISOLATE A SITE OF SURGICAL INCISION FROM MICROBIAL AND OTHER CONTAMINATION. THE OR TOWEL IS ALSO TO BE USED FOR THE ABSORPTION OF FLUIDS, INCLUDING BLOOD AND BODY FLUIDS OR AS A GENERAL USE TOWEL FOR DRYING HANDS. IT WAS NOT INTENDED TO BE USED TO WIPE DOWN THE WIRE OR CATHETERS AS DESCRIBED BY THE CUSTOMER. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME, WE WILL CONTINUE TO MONITOR FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT TOWEL LINT CLOGGED UP A CATHETER AND THEY COULD NOT PASS A GUIDE WIRE THROUGH, WHEN THEY TOOK IT OUT AND FLUSHED IT, A HUGE LINT BALL CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462414 TOWEL OR 17X24IN BLUE STERILE 4/PK TOWEL OR 17X24IN BLUE STERILE 4/PK KKX JIANERKANG MEDICAL DRESSING 28700-004 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other