BEUDAMED
    FDA Adverse Event Other Summary report: N

    TERUMO 10CC SYRINGE

    MDR report key: 350080 · Received September 4, 2001

    Report

    Report Number
    MW1022780
    Event Type
    Other
    Date Received
    September 4, 2001
    Date of Event
    August 24, 2001
    Report Date
    August 29, 2001
    Manufacturer
    TERUMO MEDICAL CORP MFG
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TERUMO 10CC SYRINGE APPLIED TO FISTULA NEEDLES FOR HEPARIN INSTILLATION PRIOR TO HEMODIALYSIS. MUST THEN REMOVE SYRINGE TO CONNECT FISTULA NEEDLE TO HEMODIALYSIS MACHINES. TIPS OF TERUMO 10CC SYRINGE REPEATEDLY BREAKING OFF IN FISTULA NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39935 TERUMO 10CC SYRINGE SYRINGE FMF TERUMO MEDICAL CORP MFG SS*10L AG1713
    39936 TERUMO 10CC SYRINGE SYRINGE FMF TERUMO MEDICAL CORP MANUFACTURING SS*10L AF0519
    39937 TERUMO 10CC SYRINGE SYRINGE FMF TERUMO MEDICAL CORP MANUFACTURING SS*10L AA1319
    39938 TERUMO 10CC SYRINGE SYRINGE FMF TERUMO MEDICAL CORP MANUFACTURING SS*10L AG1513

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other