BEUDAMED
    FDA Adverse Event Other Summary report: N

    3 CC SAF. SYR 23X1

    MDR report key: 3163077 · Received May 29, 2013

    Report

    Report Number
    1650158-2013-00001
    Event Type
    Other
    Date Received
    May 29, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 13, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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 THE SAFETY SYRINGE. THE CUSTOMER REPORTS THAT THE SAFETY SHIELD SLID DOWN BUT WOULD NOT LOOK INTO PLACE, THEN SLID UP. THE CUSTOMER STATED A NEEDLE STICK OCCURRED AS A RESULT, THE STICK WAS WITH A USED NEEDLE. THE CUSTOMER REPORTS ALL LABS HAVE BEEN NEGATIVE FOR THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233933 3 CC SAF. SYR 23X1 SAFETY SYRINGE FMF COVIDIEN 8881533338 200407328

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other