BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOFT

    MDR report key: 19947405 · Received August 9, 2024

    Report

    Report Number
    8021545-2024-03208
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    March 1, 2023
    Report Date
    September 12, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018846
    PMA / PMN Number
    K162812
    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). DEVICE 2 OF 9.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 8021545-2024-03208. 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 INVESTIGATION ASSOCIATED WITH RELATED EVENT (B)(4) HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE OMQR. THE IDENTIFIED MALFUNCTION CODE, SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE, IS NOT ASSOCIATED WITH A DESIGN OR MANUFACTURING-RELATED COMPLAINT ISSUE. THEREFORE, A DETAILED INVESTIGATION OR INSPECTION OF REFERENCE SAMPLES IS NOT REQUIRED. BATCH REVIEW: LOT 6002808 WAS MANUFACTURED ON 21-AUG-2023, IN MACHINE WITH A TOTAL OF (B)(4). THE BATCH RECORD WAS REVIEWED TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED, AND NO ISSUES WERE FOUND. REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WAS FOUND WITHIN THE DOCUMENTATION. CONCLUSION SUMMARY OF THE RELATED EVENT: DUE TO THE FOLLOWING BATCH RECORD REVIEW YIELDING NO DISCREPANCIES AND NO NC WAS GENERATED DURING PRODUCTION. DURING MANUFACTURING OF THE CANNULA PART, THE SOFT CANNULA IS KEPT STRAIGHT BY THE INTRODUCER NEEDLE, NO SAMPLES WERE RETURNED FOR INSPECTION. HOWEVER, DURING USE IN GENERAL AND SPECIFICALLY DURING INSERTION MAY ACCIDENTALLY KINK THE SOFT CANNULA. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT, IF USED/UNUSED SAMPLES ARE RECEIVED, APPROPRIATE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. IT WAS REPORTED THAT PATIENT FACED NINE INFUSION SETS CANNULA KINKED EVENTS. ALL THE EVENTS OCCURRED AFTER 3 HOURS OF INSERTION AND THE INSERTION SITE WAS AT ABDOMEN. THE SET WAS IN USE FOR 1 TO 3 DAYS. THE BLOOD GLUCOSE LEVEL AT THE TIME OF EVENTS WAS 300 MG/DL AND PATIENT RESOLVED ALL THE EVENTS BY REPLACING INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. 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
    1646537 VARISOFT UNO COMFORT 110/17 TCAP 10PK INT FPA UNOMEDICAL A/S 1002832 6002808 05705244018846

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male