BEUDAMED
    FDA Adverse Event Injury Summary report: N

    90043179 TELFA NON ADH DSG 2X3 100'S

    MDR report key: 4089962 · Received September 9, 2014

    Report

    Report Number
    1282497-2014-00047
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 12, 2014
    Manufacturer
    STRUKMYER MEDICAL
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    TWO USED SAMPLES AND 1 UNUSED BOX OF PRODUCT ID #(B)(4) TELFA STERILE 2X3 NON-ADHESIVE DRESSING WERE RECEIVED. PHOTOGRAPHS OF THE SAMPLES WERE TAKEN OF THE USED SAMPLES AND THEN WERE DISCARDED DUE TO THE BIO-HAZARDOUS NATURE OF THEM. THE BAG THE SAMPLES CAME IN WAS SOAKED WITH BLOOD AND THERE WAS BLOOD IN THE BAG. THE MYLAR WAS COMING OFF THE FIBERS AS THE DRESSINGS WERE OVERSATURATED. THE SUPPLIER VISUALLY INSPECTED THE UNUSED SAMPLES RETURNED AND THE SAMPLES WERE FOUND TO MEET PRODUCT SPECIFICATION. THE SUPPLIER VISUALLY INSPECTED RETAIN SAMPLES OF THE SAME LOT AND THE RETAIN SAMPLES DID NOT SHOW ANY SIGNS OF THE PAD BEING DELAMINATED FROM THE DRESSING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR LOT# 28743 PRODUCED IN (B)(6) OF 2014. THERE WERE NO MANUFACTURING RELATED ISSUES RELATED TO THE COMPLAINT ISSUED FOR THIS LOT. ACCORDING TO THE COMPLAINT, THE DRESSINGS WERE USED TO WIPE DOWN WIRES DURING CAROTID, CEREBRAL AND STROKE/PROCEDURE INTERVENTION AND ALSO USED TO PLACE CORE BIOPSIES TO SEND THEM TO PATHOLOGY. THE DRESSINGS WERE NOT DESIGNED FOR THAT PURPOSE. THE DRESSING IS TO BE USED PRIMARILY AS AN ABSORBENT DRESSING FOR LIGHT TO MODERATELY EXUDATING WOUNDS OR SURGICAL SITED. BASED ON THIS COMPLAINT, ALTHOUGH THE PRODUCT WAS NOT USED FOR ITS INTENDED PURPOSE, THE REPRESENTATIVE SAMPLES RETURNED MEET MANUFACTURE SPECIFICATION. NO CORRECTIVE OR PREVENTIVE ACTION IS PLANNED AT THIS TIME. A ROOT CAUSE ANALYSIS DETERMINED THE ROOT CAUSE TO BE INAPPROPRIATE USE OF THE PRODUCT FOR WHAT IT WAS INTENDED FOR. THIS COMPLAINT WILL BE RECORDED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DRESSING. THE CUSTOMER STATES THAT THE TELFA PAD FALLS APART DURING PROCEDURES, LEAVING BEHIND FIBERS. THEY HAVE BEEN ABLE TO REMOVE THE FIBERS FROM THE PT BEFORE THERE WAS ANY HARM. THE INTERVENTIONAL RADIOLOGY (IR) NURSE MANAGER STATED THAT ONES SUPPLIED IN IR ARE COVIDIEN AND DURING PROCEDURES THE LAYERS HAVE BEEN SEPARATING WHICH PUTS THE PT AT RISK FOR HARM. THESE ARE USED TO WIPE DOWN WIRES DURING CAROTID, CEREBRAL AND STROKE PROCEDURE/INTERVENTION AND ALSO USED TO PLACE CORE BIOPSIES TO SEND TO PATHOLOGY. WHEN THE LAYERS SEPARATE, THE COTTON LIKE FIBERS ADHERE TO THE WIRE AND PREDISPOSES THE PT TO HARM SINCE THE FIBER THEN ACTS AS AN EMBOLIC MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556323 90043179 TELFA NON ADH DSG 2X3 100'S NON-ADHERING DRESSING FRO STRUKMYER MEDICAL 1961 28743

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other