BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRBRD2 COBRAID 38 SNGL ARM PACK AS

    MDR report key: 11126093 · Received January 6, 2021

    Report

    Report Number
    1219602-2021-00058
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 14, 2020
    Report Date
    March 3, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    03596010547682
    PMA / PMN Number
    K041216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. AN ASSESSMENT OF THE CUSTOMER PROVIDED IMAGES CONFIRMED THE LABEL OF THE 7211081 - 74F2000680 PACKAGE IDENTIFIED THE EXPIRATION DATE AS 03 JUNE 2025. THE DELIVERY NOTE INDICATED THE EXPIRATION DATE WAS 30 JUNE 2025. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION AND CONFIRMED THE EXPIRATION DATE WAS 03 JUN 2025. ADDITIONAL INVESTIGATION FOUND THE SUPPLIER OF THE DEVICE, TELEFLEX, APPLIES AN EXACT EXPIRATION DATE TO THE PRODUCT LABEL BASED ON THE DATE OF STERILIZATION. WHEN THE PRODUCT IS RECEIVED AT SMITH + NEPHEW, THE STERILIZATION DATE ON THE CERTIFICATE OF CONFORMANCE IS MANUALLY ENTERED INTO THE SAP SYSTEM. THIS DATE IS SUBSEQUENTLY PRINTED ON THE DELIVERY NOTE WHEN ORDERS ARE PROCESSED FOR SHIPPING. FOR THIS CASE, THE SPECIFIC PART NUMBER IN SAP WAS NOT CONFIGURED TO ALLOW A SPECIFIC DAY OF THE MONTH TO BE ENTERED AND INSTEAD DEFAULTED TO THE LAST DAY OF THE MONTH CORRESPONDING TO THE DATE ENTERED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH MANUFACTURING PROCESSES. THE EXPIRATION DATE IS CORRECTLY REFLECTED ON THE DEVICE PACKAGING AND THE CURRENT END OF MONTH ROUNDING PERFORMED BY THE SAP SYSTEM AND PRINTED ON THE DELIVERY NOTE IS NOT EXPECTED TO RESULT IN ANY SAFETY OR PERFORMANCE ISSUE GIVEN 1) THE DEVICE IS LABELED CORRECTLY, 2) THE DELIVERY NOTE IS NOT A PART OF THE DEVICE LABELING AND WOULD NOT LIKELY BE USED AS AN EXPIRATION DATE REFERENCE BY THE USER, AND 3) THE DEVICES WOULD MOST LIKELY BE CONSUMED BEFORE REACHING EXPIRATION, AND 4) THE TIME PERIOD BETWEEN THE TRUE EXPIRATION DATE AND WHAT IS PRINTED ON THE DELIVERY NOTE IS NEGLIGIBLE IN COMPARISON TO THE OVERALL 5 YEAR SHELF-LIFE FOR THE PRODUCT. HOWEVER, IN ORDER TO ENSURE CONSISTENCY BETWEEN THE LABELED EXPIRATION DATE AND THE PRINTED DELIVERY NOTES FOR FUTURE SHIPMENTS, A CORRECTION TO THE PART NUMBER CONFIGURATIONS WILL BE IMPLEMENTED IN SAP.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPIRY DATE MENTIONED ON THE PACKAGING OF THE ULTRABRAID DID NOT CORRESPOND TO THE DATE INDICATED ON THE DELIVERY NOTE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23836 ULTRBRD2 COBRAID 38 SNGL ARM PACK AS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 7211081 74F2000680 03596010547682

    Patients

    Seq Age Sex Outcome Treatment
    1