BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV3000 1 HAND 10X12CM CTN 50

    MDR report key: 11327110 · Received February 15, 2021

    Report

    Report Number
    8043484-2021-00328
    Event Type
    Malfunction
    Date Received
    February 15, 2021
    Date of Event
    January 11, 2021
    Report Date
    March 17, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KDX
    UDI-DI
    05000223417406
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE NOW CONCLUDED OUR INVESTIGATION FOR THE COMPLAINT RECEIVED. A REVIEW OF THE ASSOCIATED BATCH MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES DOCUMENTED IN THE BATCH MANUFACTURING RECORDS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE ISSUE HIGHLIGHTED BY THE COMPLAINANT. IN ADDITION IT CAN BE CONFIRMED THAT ALL FINISHED PRODUCT SPECIFICATION TESTING WAS SATISFIED AT THE POINT OF RELEASE. THE COMPLAINT HISTORY FILE CONTAINS NO FURTHER INSTANCES/ RELATED EVENTS OF THE REPORTED EVENT. IT WAS REPORTED THAT THE PRODUCT INTENDED TO BE USED FOR TREATMENT WAS FOUND TO HAVE NO ADHESIVE ON THE RELEASE PAPER. THE RETURNED SAMPLES WERE EVALUATED WHICH CONFIRMED A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE. LOW ADHESION MAY BE CAUSED BY ADHESION LEVELS OF THE RAW MATERIAL USED TO MAKE THE FILM OF THIS DRESSING. THERE ARE VARIOUS CONTROLS IN PLACE DURING THE MANUFACTURING PROCESS OF BOTH THE RAW MATERIAL AND THE DRESSING TO IDENTIFY WHEN THE ADHESION IS NOT IN ACCEPTABLE RANGE, AS PER THE PRODUCT SPECIFICATION. THERE ARE ALSO REGULAR TESTS CARRIED OUT TO MONITOR THE FINISHED PRODUCT. THE ROOT CAUSE WAS TRACED TO THE MANUFACTURING PROCESS. AS THE OCCURRENCE OF MISSING ADHESIVE IS WITHIN ACCEPTABLE RANGE, NO FURTHER ACTIONS ARE DEEMED NECESSARY AT THIS STAGE. HOWEVER, THE DETAILS OF THIS COMPLAINT WILL BE SHARED WITH THE RELEVANT MANUFACTURING TEAM. SMITH AND NEPHEW ACKNOWLEDGE CUSTOMER CONCERN AND ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS. WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE. (B)(4)

    Additional Manufacturer Narrative · 1

    CASE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE NURSE TRIED TO CHANGE THE IV3000 DRESSING OF THE PICC FOR THE PATIENT, IT WAS FOUND THAT THE FILM WAS SEPARATED FROM THE PROTECTION PAPER, SO IT WAS THEN REPLACED WITH ANOTHER DRESSING. IT IS UNKNOWN IF THERE WAS A DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227498 IV3000 1 HAND 10X12CM CTN 50 SOLUTION, DECALCIFIER, ACID CONTAINING KDX SMITH & NEPHEW MEDICAL LTD. 1925 05000223417406

    Patients

    Seq Age Sex Outcome Treatment
    1