BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV3000 SHAPED 12X9CM CTN 50

    MDR report key: 8663830 · Received June 3, 2019

    Report

    Report Number
    8043484-2019-00376
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 7, 2019
    Report Date
    August 23, 2019
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE NOW CONCLUDED OUR INVESTIGATION INTO THIS COMPLAINT. THE BATCH RECORDS WERE REVIEWED AND IT COULD BE CONFIRMED THAT THE PRODUCTS HAD PROGRESSED THROUGH A SATISFACTORY RELEASE PROCESS WHICH INVOLVED TESTING THE PRODUCT AGAINST THE REQUIREMENTS OF ITS FINISHED PRODUCT SPECIFICATION. THERE WAS NO ISSUE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE ISSUE. DUE TO NO SAMPLE, NO THOROUGH INVESTIGATION CAN BE CARRIED OUT. NO TRUE ROOT CAUSE CAN BE IDENTIFIED FOR THIS ISSUE, HOWEVER A POTENTIAL ROOT CAUSE CAN BE THE ADHESIVE PROCESSING OF THE PRODUCT. GENERALLY, WHERE MORE ADHESIVE IS PRESENT, THE ADHESIVE PERFORMANCE IS INCREASED. DURING THE ADHESIVE SPREADING PROCESS, IN-PROCESS CHECKS ARE UNDERTAKEN FOR THIS PRODUCT. EACH ROLL OF ADHESIVE SPREAD MATERIAL IS CHECKED TO ENSURE THE CORRECT ADHESIVE WEIGHT HAS BEEN APPLIED. ONLY PRODUCT MEETING THE RELEASE CRITERIA WILL BE PASSED ON FOR FURTHER PROCESSING. IN THE ABSENCE OF ADDITIONAL INFORMATION, OUR INVESTIGATION REMAINS INCONCLUSIVE. AT THIS TIME AN EXACT ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS CASE WILL BE REOPENED. SMITH AND NEPHEW ACKNOWLEDGE CUSTOMER CONCERN AND ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT DOES NOT LAST, MUST BE REPLACED WITH A NEW ONE. GENERALLY, THE ADHESIVE IS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457261 IV3000 SHAPED 12X9CM CTN 50 TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. 1851

    Patients

    Seq Age Sex Outcome Treatment
    1