BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-T PARADIGM

    MDR report key: 20105552 · Received August 30, 2024

    Report

    Report Number
    3003442380-2024-23164
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    July 31, 2024
    Report Date
    October 10, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 PR.(B)(4) HAS BEEN EVALUATED. THE BATCH 6004459 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION-3802038 GUIDELINE 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 INSTRUCTION-4A02025 VERSION 18. TEST ON RETURNED UNUSED/USED/REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WORK INSTRUCTION-4802104 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 6004459 WAS MANUFACTURED ACCORDING TO THE DOCUMENT 4905115 VERSION 45 ON THE PACKING PROCESS IN THE MACHINE 10, ON 29/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE 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 NC RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    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 CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON 31-JUL-2024. THE INFUSION SET WAS IN USE FOR 1 HOUR. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802634 SURE-T PARADIGM UNO CONTACT DETACH G29 60/8 SC1 MIMX FPA UNOMEDICAL A/S MMT-874A 6004459

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown