BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE T INFUSION SITE

    MDR report key: 6979192 · Received October 26, 2017

    Report

    Report Number
    MW5072960
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    October 16, 2017
    Report Date
    October 24, 2017
    Manufacturer
    MEDTRONIC MINIMED INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SON IS A TYPE 1 DIABETIC (B)(6). DIAGNOSED AT (B)(6), HAS BEEN USING MINIMED MEDTRONIC INSULIN PUMP SINCE 2008. HAVING PROBLEMS WITH THE INFUSION SET SPECIFICALLY THE SURE T. RECENT RECALL AND THE SHORTAGE OF THAT IS OWED BACK TO US AFTER SENDING IN THE RECALLED BOXES. THE NEWEST PROBLEM IS ON (B)(6) 2017 (B)(6) PUT A NEW SURE T SITE IN HIS BODY AND IN ABOUT 90 MINUTES OF PUTTING IT IN, IT BROKE FROM HIM BENDING OVER. THE TUBING BROKE AWAY FROM THE PUMP. THANKFULLY WE WERE HOME AND ABLE TO DEAL WITH CHANGING HIS SITE ASAP. I CALLED MEDTRONIC ABOUT THIS AND REQUESTED A NEW BOX (THIS BOX WAS A REPLACEMENT FROM THE CURRENT RECALL). THEY BASICALLY WERE NOT INTERESTED IN MY NEW ISSUE AND SAID THEY WOULD SEND ONE SITE TO REPLACE AND I NEED TO SEND THE BROKEN ONE IN A CANISTER. I SAID I WANT TO REPLACE THE WHOLE BOX AS I DO NOT TRUST THIS BOX. I ALSO REQUESTED A 2ND BOX TO REPLACE THE BOX I SENT IN FROM THE RECALL. MEDTRONIC SENT ME ONE BOX AND AN ENVELOPE. HOW AM I SUPPOSED TO RETURN A NEEDLE SAFELY IN AN ENVELOPE? THEY HAVE NOT RETURNED CALLS OR REACHED OUT TO ME EVEN THOUGH I HAVE BEEN MESSAGING THEM ON (B)(6) ASKING FOR A SUPERVISOR TO CALL ME. BOTTOM LINE IS THE TUBING BREAKING IS THE EXACT SAME PROBLEM FROM A RECALL A FEW YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760753 SURE T INFUSION SITE SET, ADMINISTRATION, INTRAVASCULAR FPA MEDTRONIC MINIMED INC. MMT876 5199712

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention