BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19947104 · Received August 9, 2024

    Report

    Report Number
    3003442380-2024-20271
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 2, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244006331
    PMA / PMN Number
    K070430
    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 COMPLAINT (B)(4) HAS BEEN EVALUATED ACCORDING TO MALFUNCTION. THE LOT 6002746 IN QUESTION WAS PRODUCED AT REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WORK INSTRUCTIONS (WI) VERSION 11. COMPLAINT INVESTIGATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR CLICK AND STATIC PULL TEST BASE-CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE FOLLOWING TEST WAS PERFORMED: VISUAL INSPECTION: (VERSION.8) CONNECTOR QUALITY CRITERIA FOR PRINTING. FUNCTIONAL 1.- (VERSION.9) QUALITY ALERT CLICK TEST. FUNCTIONAL 2.- (VERSION.45) INSTRUCTIONS FOR STATIC PULL TEST. BATCH REVIEW: THE BATCH LISTED IN THE DATABASE COMPLAINT PARENT RECORD WAS REVIEWED AND CONFIRMED TO BE ACCURATE. UNO QUICK-SET 60/6 PCC MECA WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1310003 AND MANUFACTURING LOT NUMBER 6002746 ON (B)(6)2023 AND (B)(4) FINAL UNITS IN THE MACHINES (B)(4) WERE MANUFACTURED. THE BATCH RECORD CONFIRMS THIS INFORMATION. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT FROM SITE ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 1 DAY. THE INFUSION SET WAS INSERTED IN ABDOMEN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634986 QUICK SET PARADIGM UNO QUICK-SET 60/6 PCC MECA FPA UNOMEDICAL A/S MMT-399 6002746 05705244006331

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown