BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-40 MONOJECT !/2 ML SYRINGE 25G X1/2 "

    MDR report key: 10288753 · Received July 16, 2020

    Report

    Report Number
    MW5095560
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 14, 2020
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    UDI-DI
    20884527023340
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) ATTEMPTED TO ADMINISTER VETSULIN TO MY DOG. GLUCOSE LEVEL RISING QUICKLY OVER 400. WHEN INSERTED NEEDLE INTO VIAL COULD NOT DRAW UP INSULIN. TRIED MULTIPLE TIMES. NEEDED TO CHANGE OUT SYRINGE FOR NEW DEVICE. THIS IS SECOND TIME THIS HAS OCCURRED USING THE CARDINAL U40 SYRINGE. REPORTED TO CARDINAL HEALTH AND REQUESTED SECURE RETURN PACKAGE (BIOHAZARD PACKAGE) AS OF (B)(6) NO PACKAGE TO RETURN DEVICE. LAST INVESTIGATION OF PREVIOUS DEVICE FAILURE CARDINAL TRIED TO BLAME ME FOR STORING INSULIN IN SYRINGE. SENT RESPONSE THAT I ALWAYS USE FRESH SYRINGE SO STATED INVESTIGATION WAS FALSE. AGAIN TO DATE NO RETURN PACKAGE FOR DEVICE INVESTIGATION. HERE IS COPY OF EMAIL SENT TO CARDINAL ON (B)(6): GOOD MORNING (B)(6), I HAVE ANOTHER DEFECTIVE SYRINGE. HERE IS THE INFORMATION. PRODUCT NAME: MONOJECT U-40, 1/2 ML INSULIN SYRINGE, 29G X 1/2" REF #: 8881500042, LOT NUMBER: 011134, EXPIRATION DATE: 01/31/2025 DEFECT: WHEN DELIVERING MY DOGS VETSULIN ON (B)(6) 2020 AFTER MIXING THE INSULIN BOTTLE AS REQUIRED BY THE MANUFACTURER, I OPENED A FRESH INSULIN SYRINGE. AFTER PLACING THE NEEDLE IN THE BOTTLE AND ATTEMPTING TO DRAW UP THE VETSULIN, NOTHING WOULD ENTER THE BARREL. I TRIED MULTIPLE TIMES (LEAVING THE NEEDLE IN THE SYRINGE AND BRINGING THE BARREL TO 0 AND DRAWING AGAIN. THE SYRINGE WAS REPLACED WITH ANOTHER FRESH SYRINGE AND I WAS ABLE TO DELIVER MY DOG, (B)(6), INSULIN. JUST TO CLARIFY DUE TO A PREVIOUS INVESTIGATION WITH A SIMILAR DEFECT AND YOUR OUTCOME WHICH I NEEDED TO CORRECT, I DID NOT STORE INSULIN IN THE SYRINGE. THIS WAS A FRESHLY OPENED SYRINGE AND ONLY OPENED AFTER I THOROUGHLY MIXED THE BOTTLE. CONTACT NUMBER: (B)(6), COMPLAINT FILED BY (B)(6), RESULT OF INVESTIGATION REQUIRED: YES, PLEASE SEND BY EMAIL OR REGULAR MAIL. REQUEST: PLEASE SEND A SECURE CONTAINER FOR RETURN OF THE SYRINGE AS WELL AS A RETURN LABEL. I WILL NOT SEND THE SYRINGE BACK UNLESS IT IS PROTECTED FROM INADVERTENT PUNCTURE DURING MAILING TO YOUR LABORATORY. CARDINAL IS NOT TAKING INVESTIGATION AND COMPLAINT SERIOUSLY. BEST REGARDS, (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751144 U-40 MONOJECT !/2 ML SYRINGE 25G X1/2 " SYRINGE, PISTON FMF COVIDIEN 8881500042 011134 20884527023340
    751145 U-40 MONOJECT !/2 ML SYRINGE 25G X1/2 " SYRINGE, PISTON FMF CARDINAL HEALTH 200, LLC 011134

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other