BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SAFETOUCH II AVF NEEDLE

    MDR report key: 11036290 · Received December 18, 2020

    Report

    Report Number
    8041145-2020-00019
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Date of Event
    November 9, 2020
    Report Date
    March 31, 2021
    Manufacturer
    NIPRO (THAILAND) CORP. LTD.
    Product Code
    FOZ
    UDI-DI
    00383790000147
    PMA / PMN Number
    K032777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. THIS FACILITY HAS USED SAFETOUCH II SINCE (B)(6) 2019. THE CLINICAL SPECIALIST PROVIDED TRAINING ON WEDNESDAY, (B)(6) 2019, WEDNESDAY, (B)(6) 2019, AND WEDNESDAY, (B)(6) 2020 TO PROVIDE SUPPLEMENTAL TRAINING AND SUPPORT.

    Description of Event or Problem · 1

    SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. THIS FACILITY HAS USED SAFETOUCH II SINCE MARCH 11, 2019. THE CLINICAL SPECIALIST PROVIDED TRAINING ON WEDNESDAY, JANUARY 23, 2019, WEDNESDAY, MARCH 27, 2019, AND WEDNESDAY FEBRUARY 26, 2020, TO PROVIDE SUPPLEMENTAL TRAINING AND SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506097 NIPRO SAFETOUCH II AVF NEEDLE AVF NEEDLE FOZ NIPRO (THAILAND) CORP. LTD. FS+162530BC 20C19 00383790000147

    Patients

    Seq Age Sex Outcome Treatment
    1 Other