BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 20029550 · Received August 22, 2024

    Report

    Report Number
    3003442380-2024-21786
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 2, 2024
    Report Date
    October 1, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019584
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION ASSOCIATED WITH RELATED EVENT (B)(4) HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVELLIENCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (MQR) PROCEDURE. THE IDENTIFIED MALFUNCTION CODE, TUBING IS DAMAGED (E.G. KINKED, DEFORMED, TWISTED, COLLAPSED OR PINCHED), IS NOT ASSOCIATED WITH A DESIGN OR MANUFACTURING-RELATED COMPLAINT ISSUE. THEREFORE, A DETAILED INVESTIGATION OR INSPECTION OF REFERENCE SAMPLES IS NOT REQUIRED. BATCH REVIEW: LOT 6004713 WAS MANUFACTURED ON 07-DEC-2023, IN MACHINE 10, WITH A TOTAL OF (B)(4). THE BATCH RECORD WAS REVIEWED TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED, AND NO ISSUES WERE FOUND. REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WAS FOUND WITHIN THE DOCUMENTATION. CONCLUSION SUMMARY OF THE RELATED EVENT: DUE TO THE FOLLOWING BATCH RECORD REVIEW YIELDING NO DISCREPANCIES AND NO NON-CONFORMANCE (NC) WAS GENERATED DURING PRODUCTION. IN THE MANUFACTURING PROCESS THE TUBING IS INSPECTED AGAINST SPECIFICATIONS BEFORE RELEASED FOR PRODUCTION. HOWEVER, DURING USE COULD ALSO ACCIDENTALLY KINK THE TUBING BY WINDING IT OR GETTING THE TUBING CAUGHT ON OR IN SOMETHING. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 02/JUL/2024, THE PATIENT REPORTED THAT INFUSION SET TUBING WAS KINKED / BENT. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286929 SILHOUETTE PARADIGM UNO COMFORT SHORT 60/13 SC1 MIN FPA UNOMEDICAL A/S MMT-381A 6004713 05705244019584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown