BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET I 60/9 GREY T-CAP

    MDR report key: 19926535 · Received August 7, 2024

    Report

    Report Number
    3003442380-2024-19133
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    June 24, 2024
    Report Date
    October 21, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026001
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-19133. 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. THE BATCH 6003404 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. . INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS GUIDELINES FOR TEST OF REFERENCE SAMPLES BUID-UMD VERSION 11 FOR THE CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH WORK INSTRUCTIONS VERSION 31 TEST ON RETURNED UNUSED/USED/REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WORK INSTRUCTIONS VERSION 4 TEST ON RETURNED UNUSED/USED/REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6003404 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 107 ON THE PACKING PROCESS IN THE LINE 5, ON 26/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFROMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT, THE PATIENT FACED ISSUE WITH 2 INFUSION SET TUBING ON (B)(6) 2024 WHICH OCCURED WITHIN A DAY BEFORE SITE CHANGE AND SECOND FOR NO MORE THAN 12 HOURS. THE TUBING DETACHED FROM THE CONNECTOR WHICH WAS RESOLVED BY REPLACING INFUSION SET AND RESUMING INSULIN. 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
    264418 INSET I 60/9 GREY T-CAP INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010900 6003404 05705244026001

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male