BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV3000 1 HAND 6X7CM CTN 100

    MDR report key: 10185242 · Received June 23, 2020

    Report

    Report Number
    8043484-2020-00929
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    May 14, 2020
    Report Date
    May 6, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    UDI-DI
    04582111150981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE USED IN TREATMENT WAS NOT RETURNED FOR EVALUATION, ALL PROVIDED INFORMATION HAS BEEN REVIEWED AND WE HAVE NOT BEEN ABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE REPORTED EVENT OR DETERMINE A ROOT CAUSE. PROBABLE ROOT CAUSE DETERMINED AS APPLICATION TECHNIQUES OR A PRODUCT FAILURE. THE IFU HAS BEEN REVIEWED AND CONTAINS COMPREHENSIVE INSTRUCTIONS ON THE SAFE OPERATION AND USE OF THE DEVICE. THE ASSOCIATED RISK FILES CONTAIN DETAILS RELATING TO HARM. HOWEVER, THE CLINICAL REVIEW HAS NOT ESTABLISHED A CAUSAL LINK. ADDITIONAL RMR IS NOT REQUIRED, FILE RESIDED WITH THE HULL DQA TEAM. THE MANUFACTURING RECORDS SHOW NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATION AT THE TIME OF MANUFACTURE. THE COMPLAINT HISTORY FILE CONTAINS FURTHER INSTANCES. THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY. SMITH + NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PERIPHERALLY INSERTED CENTRAL CATHETER WAS PASSED IN MSE IN THE FIRST PUNCTURE ATTEMPT AND IT WAS FIXED WITH IV 3000. RX WAS PERFORMED AND THE CATHETER WAS CONFIRMED AND RELEASED FOR USE. TRANSPARENT DRESSING SHOWED TOTAL LOOSENING 40 MINUTES AFTER CAUSING THE CATHETER TO BE EXTERIORIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648764 IV3000 1 HAND 6X7CM CTN 100 TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. 201937 04582111150981

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention