BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 20004735 · Received August 20, 2024

    Report

    Report Number
    3003442380-2024-21791
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 20, 2024
    Report Date
    September 3, 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 COMPLAINT (B)(4) HAS BEEN EVALUATED ACCORDING TO MALFUNCTION. PRIMARY PACK HAS INCOMPLETE OR OPEN SEAL/WELD, IS TORN, RIPPED, CONTAINS HOLES, EXHIBITS EXTERNAL CONTAMINATION (E.G. WATER MARKS, STAINS), OR PRODUCT IS TRAPPED IN PACKAGING (E.G. TRAPPED IN WELD). THE LOT 6003219 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. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE FOLLOWING TEST WAS PERFORMED: VISUAL INSPECTION: (VERSION.33) PACKAGING AREA SAMPLER FOR PRODUCTS PACKED IN MULTIVAC MACHINES- SAMPLER BOOK FOR PRODUCTS PACKED ON M.DOC. BATCH REVIEW: THE BATCH LISTED IN THE DATABASE COMPLAINT PARENT RECORD WAS REVIEWED AND CONFIRMED TO BE ACCURATE. UNO QUICK-SET 60/6 SC1 MECA WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1728390 AND MANUFACTURING LOT NUMBER 6003219 ON 17-SEP-2023 AND (B)(4) FINAL UNITS IN THE MACHINES 12 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 : SPAIN.

    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 SPAIN. ON (B)(6) 2024, PATIENT REPORTED THAT DETAILS MISSING FROM THE PACKAGING OF INFUSION SET AND NOT SEALED PROPERLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395657 MINMED QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6003219 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown