BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19592791 · Received June 24, 2024

    Report

    Report Number
    3003442380-2024-10001
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 25, 2024
    Report Date
    October 1, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: 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 SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR). THE IDENTIFIED MALFUNCTION SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, 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 6002186 WAS MANUFACTURED ON 18/JUL/2023, IN MACHINE 12, 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: DUE TO THE FOLLOWING BATCH RECORD REVIEW YIELDING NO DISCREPANCIES AND NO NON-CONFORMANCE (NC) WAS GENERATED DURING PRODUCTION. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT. THE ACRYLIC GLUE ON THE ADHESIVE IS NOT APPLIED BY CONVATEC AND THE ADHESIVE MATERIAL HAS BEEN MANUFACTURED AND INSPECTED IN ACCORDANCE WITH ALL SPECIFICATIONS, BATCH DOCUMENTATION AND THE REQUIREMENTS ACCORDING TO 21 CFR PART 820: QUALITY SYSTEM REGULATION AND ISO EN 13485:2016: MEDICAL DEVICES-QUALITY MANAGEMENT SYSTEMS.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6)PATIENT COUNTRY: (B)(6)

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA CRIMPED EVENT ON (B)(6)2024.THE EVENT OCCURRED ON THE SECOND DAY AFTER INSERTION. INSERTION SITE WAS ABDOMEN. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194675 QUICK SET PARADIGM UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6002186 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown