BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM SURE-T

    MDR report key: 4193835 · Received October 9, 2014

    Report

    Report Number
    3003442380-2014-00086
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    April 1, 2014
    Report Date
    October 9, 2014
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGES TO THE STEEL INTRODUCER NEEDLE CAN OCCUR DURING SEVERAL STEPS IN MFG. TO PREVENT SYSTEMATIC FAILURES DURING MFG, UNOMEDICAL USES ONLINE SAMPLING PLANS ACCORDING TO ISO 2859-1. SAMPLE SIZES ARE TESTED AGAINST SPECIFICATIONS. FURTHERMORE, DURING USE THE PT COULD ACCIDENTALLY DAMAGE THE STEEL INTRODUCER NEEDLE. POSSIBLE CAUSES TO BROKEN OR DAMAGED NEEDLES COULD BE ALTERATION OF THE STEEL INTRODUCER NEEDLE ANGLE, STORING THE BLISTER PACKS UNPROTECTED, USING WRONG INSERTION TECHNIQUES OR CHOOSING INFUSION SITES OTHER THAN THOSE RECOMMENDED.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER REPORTED NEEDLE BREAK INSIDE HIS SON BODY. BLOOD GLUCOSE VALUE: 89 MG/DL LAST TIME, ABOUT 600 MG/DL BEFORE. FATHER DID NOT HAVE ACCESS TO THE CHILD DURING CALL. FATHER ALREADY TOOK OUT INFUSION SET, NEEDLE LEAVED IN THE BODY. PT WAS NOT UNDER ANESTHESIA. FATHER IS A HCP; PT WAS NOT HOSPITALIZED AND DID NOT FELL PAIN. THERE ARE MULTIPLE LOT NUMBERS GIVEN: # 5040467, 5034327, 5023463, 5047582, 5028965.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636917 PARADIGM SURE-T CONTACT DETACH PCC G29 FPA UNOMEDICAL A/S 5040467

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention