BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEUKOSTRIP 13X102MM CTN 50

    MDR report key: 14191044 · Received April 23, 2022

    Report

    Report Number
    8043484-2022-00125
    Event Type
    Malfunction
    Date Received
    April 23, 2022
    Date of Event
    April 1, 2022
    Report Date
    July 20, 2022
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    MZR
    UDI-DI
    05000223449186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE PRODUCT HAS BEEN RETURNED AND EVALUATED, THE EVENT IS CONFIRMED. VISUAL INSPECTION OF THE DRESSING HAS CONFIRMED THE REPORTED CONTAMINATION, THIS HAS BEEN CONFIRMED TO BE ADDITIONAL ADHESIVE, THIS IS NOT ANY OTHER FORM OF CONTAMINATION. A DOCUMENTATION REVIEW HAS REVEALED PREVIOUSLY CASES WITH A SIMILAR NATURE, THERE ARE NO OPEN CORRECTIVE ACTIONS. THE MANUFACTURING RECORDS CONFIRM THE DEVICE MET THE FINAL PRODUCT SPECIFICATIONS AND CONTAIN NO CONTRIBUTORY FACTORS TO THE REPORTED EVENT, A REVIEW OF THE MANUFACTURING PROCESS HAS REVEALED THE PROBABLE ROOT CAUSE. THE ASSOCIATED RISK FILES MITIGATE THIS EVENT TYPE. A PROBABLE ROOT CAUSE IS RELATED TO TRAINING, THE CONTAMINATION, IS ADDITIONAL ADHESIVE, WHICH CAN BE FOUND ON THE RAW MATERIAL. THIS, ONCE LOCATED SHOULD BE PICKED OUT PREVENTING THIS FROM REACHING THE PRODUCT MARKET. RETRAINING HAS BEEN CONDUCTED TO REDUCE THE PROBABILITY OF FUTURE OCCURRENCES. NO CORRECTIVE ACTIONS ARE DEEMED NECESSARY, AT THIS STAGE, SMITH AND NEPHEW WILL CONTINUE TO MONITOR FOR ADVERSE TRENDS RELATING TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING SET UP OR INSPECTION BEFORE USE, IT WAS CONFIRMED THERE WAS A FOREIGN SUBSTANCE IN THE STERILE POUCH. A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A DELAY. NO INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795873 LEUKOSTRIP 13X102MM CTN 50 TOPICAL APPROXIMATION SYSTEM MZR SMITH & NEPHEW MEDICAL LTD. 66002880 2119A 05000223449186

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown