BEUDAMED
    FDA Adverse Event Other Summary report: N

    M103S-PLK PTD BULK SP

    MDR report key: 3733368 · Received March 26, 2014

    Report

    Report Number
    1017768-2014-00009
    Event Type
    Other
    Date Received
    March 26, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SYRINGE. THE CUSTOMER REPORTED THERE HAD BEEN AN ISSUE RELATED TO THE SUBSTITUTED SYRINGE AND INVOLVED PATIENT IMPACT. THE CUSTOMER REPORTS AN ANTERIOR VITRECTOMY HAD TO BE PERFORMED. THE SYRINGES ARE BEING USED FOR HYDRO DISSECTION AND HYDRATING THE WOUND. THE LUER LOCK TIP DESIGN DOES NOT ALLOW FOR SECURELY ATTACHING A CANNULA UNDER PRESSURE OF BSS, THE CANNULAS HAVE A TENDENCY TO FLY OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176647 M103S-PLK PTD BULK SP SYRINGE FMF COVIDIEN 8881103066 329456X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other