BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-SET

    MDR report key: 19758946 · Received July 17, 2024

    Report

    Report Number
    3003442380-2024-14699
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 16, 2024
    Report Date
    December 2, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K070430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1913736 - MDR 3003442380-2024-14699 - DEVICE 2 OF 4. E1: (B)(6).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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. REVISION 21 OF PROCEDURE (B)(4), A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DHR REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DHR REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001901, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001901 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 76 AND MANUFACTURED IN THE MACHINE MULTIVAC 12 ON 19/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY: THE LOT 3F02445 WAS ASSEMBLED ACCORDING TO WI VERSION 26 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 18/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F02446 WAS ASSEMBLED ACCORDING TO WI VERSION 26 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 18/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F02447 WAS ASSEMBLED ACCORDING TO WI VERSION 26 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 19/JUN/2023, WITH A TOTAL OF (B)(4) UNITS GLUE-TUBING LOT: THE LOT 3F02150 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE MP04 ON 15/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F02152 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE MP08 ON 13/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F02429 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE MP04 ON 17/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F02433 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE MP04, MP05 AND MP08 ON 15/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F02434 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE MP08 ON 15/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. WELDING: THE LOT 3F02671 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 AND MANUFACTURED IN THE MACHINE US05 ON 16/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F02682 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 AND MANUFACTURED IN THE MACHINE US05 ON 18/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F02685 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 AND MANUFACTURED IN THE MACHINE US06 ON 17/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. ON (B)(6) 2024, IT WAS REPORTED TBY THE PATIENT THAT HE RECEIVE AN ALARM WITH FOUR INFUSION SET. IN TROUBLESHOOTING BLOCKAGE WAS FOUND IN TUBING. 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
    570897 QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6001901 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown