BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOFT INFUSION SET

    MDR report key: 24119561 · Received January 20, 2026

    Report

    Report Number
    MW5182508
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    January 11, 2026
    Report Date
    January 13, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USE VARISOFT INFUSION SETS. THE TUBING WORE AWAY/RIPPED OFF AT THE CONNECTION TO MY T-SLIM INSULIN PUMP. THE TUBING LOOKED LIKE IT WAS WORN AWAY AS IT LOOKED VERY THIN, KINDA LIKE IF YOU PULL AND BEND A PLASTIC TUBE IT WILL EVENTUALLY BREAK. THIS IS THE THIRD TIME THIS HAS HAPPENED IN THE LAST MONTH. THE FIRST TWO TIMES IT HAPPENED; I BLAMED IT ON A NEW PUMP CASE I WAS USING. HOWEVER, THE THIRD TIME IT HAPPED, I HAD SWITCHED BACK TO MY OLD CASE WHICH I HAD BEEN USING FOR THE PAST 4+ YEARS AND NEVER HAD THIS PROBLEM. UNFORTUNATELY, I DIDN'T GET PHOTOS OF THE SET, AS IT DIDN'T OCCUR TO ME THAT IT COULD BE A FAULTY INFUSION SET UNTIL I GOOGLED IT. PATIENT CODE: 1905. DEVICE CODE: 1153; 4008. REFERENCE REPORT#: MW5182507; MW5182509.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174287 VARISOFT INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S 1002828 6012517

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other ALENDRONATE SODIUM.| ALEVE.| ATORVASTATIN.| CALCIUM.| DEXCOM G6 CONTINUOUS GLUCOSE MONITOR.| DILTIAZEM.| HUMALOG INSULIN.| MAGNESIUM.| TANDEM T-SLIM INSULIN PUMP.| TYLENOL.| VITAMIN D.| ZINC.