BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFEX ACCESS ADV POS KIT

    MDR report key: 13087731 · Received December 27, 2021

    Report

    Report Number
    1643264-2021-02493
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    November 1, 2021
    Report Date
    September 27, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KQZ
    UDI-DI
    00885556714126
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-0635-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    B5: IT WAS INTERNALLY IDENTIFIED THAT NON-STERILE ACUFEX ACCESS ADVANCED POSITIONING KIT WAS SHIPPED TO THE GLOBAL DISTRIBUTION CENTER INSTEAD OF THE STERILIZER AND THEREFORE DID NOT UNDERGO THE APPLICABLE STERILIZATION PROCESS. THIS HAS BEEN REPORTED UNDER 21 CFR 803 AS A REMEDIAL ACTION WAS INITIATED TO ADDRESS THIS ISSUE. NO COMPLAINTS RELATED TO STERILITY OR INFECTION ASSOCIATED WITH THIS ISSUE. D4: THE FOLLOWING ARE THE LOT NUMBERS IMPACTED: 50971615, 50971617, AND 50967788. H4: DEVICE MANUFACTURE DATE FOR EACH OF THE THREE LOTS THAT ARE IMPACTED: 12 OCT 2021 (LOTS 50971615 AND 50971617) AND 20 SEP 2021 (LOT 50967788). H9: REFERENCE NUMBER IN SECTION H9 OF INITIAL REPORT IS SMITH+NEPHEW INTERNAL REFERENCE NUMBER SPECIFIC TO THIS REMEDIAL ACTION. G2: USER FACILITY CHOICE WAS INADVERTENTLY SELECTED IN INITIAL REPORT. ADDITIONALLY, CORRECTED INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: D4, E2, H7, AND H10.

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THERE WAS A RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH A FAULT DURING THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE RECORDS FOUND A NON CONFORMANCE ASSOCIATED WITH THE REPORTED LOTS. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. A REVIEW OF THE MANUFACTURING PROCESS FOUND UPDATES TO STANDARD PRACTICES, PROVIDING ADDITIONAL CLARIFICATION FOR IDENTIFICATION AND SHIPMENT OF STERILIZED PRODUCT AS A RESULT OF ESCALATION ACTIONS RELATED TO THIS EVENT. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A CORRECTIVE ACTION WAS IMPLEMENTED TO MITIGATE FUTURE RECURRENCE OF THE REPORTED EVENT AND A FIELD ACTION WAS INITIATED TO RECALL THE PRODUCT. CORRECTION IN H9.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SUPPLY CHAIN IDENTIFIED THE ACUFEX ACCESS ADVANCED POSITIONING KIT THAT WAS NOT PROCESSED IN THE STANDARD MANNER; COMPROMISING THE STERILITY OF THE DEVICES CONTAINED IN THE BATCH. AT THIS TIME IT IS UNKNOWN IF THE DEVICE WAS USED ON THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988811 ACUFEX ACCESS ADV POS KIT COMPONENT, TRACTION, NON-INVASIVE KQZ SMITH & NEPHEW, INC. 72205104 SEE H10 00885556714126

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown