BEUDAMED
    FDA Adverse Event Other Summary report: N

    1CC SAF SYR ETB 25X 5/8

    MDR report key: 3252618 · Received July 19, 2013

    Report

    Report Number
    1915484-2013-00017
    Event Type
    Other
    Date Received
    July 19, 2013
    Report Date
    June 21, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN INSULIN SAFETY SYRINGE. THE CUSTOMER REPORTS THAT THE NEEDLE IS SPINNING ON TOP OF THE SYRINGE. THE CUSTOMER ALSO REPORTS THAT A PIECE OF THE GREEN PLASTIC COMPONENT FROM INSIDE THE SYRINGE OR THE HUB IS ON THE TIP OF THE NEEDLE. BASED ON A PRELIMINARY REVIEW OF THE SAMPLES, AND ADDITIONAL FOLLOW UP WITH THE MFG FACILITY IT WAS DETERMINED THAT THE SAFETY SHIELD WAS SPINNING ON THE COLLAR, THE NEEDLE WAS NOT SPINNING IT WAS STATIONARY. PER THE MFG PLANT THE SAFETY DEVICE WAS OVER TORQUED WHICH WOULD HAVE ALLOWED THE CUSTOMER TO UNLOCK THE SAFETY DEVICE. ALTHOUGH NO PRODUCT MALFUNCTION OCCURRED, AN MDR IS BEING FILED BASED ON THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337974 1CC SAF SYR ETB 25X 5/8 INSULIN SAFETY SYRINGE FMF COVIDIEN 8881511235 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK