BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFESTEP HUBER NEEDLE SET 20G X 1 IN

    MDR report key: 9727919 · Received February 19, 2020

    Report

    Report Number
    3006260740-2020-00549
    Event Type
    Injury
    Date Received
    February 19, 2020
    Report Date
    February 19, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FPA
    UDI-DI
    00801741066221
    PMA / PMN Number
    K153440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MS&S, "CALLER ASKING FOR THE MATERIAL CONTENTS OF THE SAFESTEP PORT ACCESS NEEDLE. SHE STATES SHE IS HAVING A REACTION TO THIS DEVICE PRODUCT CODE LH-0032. SHE STATES HER SKIN IS RED AND BLISTERING. SHE STATES SHE HAS USED THE DELTEC GRIPPER PLUS DEVICE WITH 3M SENSITIVE TAPE AND IV3000 WITHOUT ISSUE. SHE STATES HER INSURANCE CHANGED AND SENT THE SAFESTEP NEEDLE USED WITH THE SAME 3M SENSITIVE TAPE AND IV3000 BUT NOW HAVING ISSUES. THE DOCTOR INSTRUCTED HER TO CHANGE BACK TO THE DELTEC PRODUCT BUT THE INSURANCE COMPANY WILL NOT ALLOW IT. MS&S "EXPLAINED THAT THE SAFESTEP NEEDLE ITSELF IS STAINLESS STEEL. THE TUBING AND HOUSING (FLUID PATH) CONTAIN PVC RIGID AND FLEXIBLE, ABS, POLYCARBONATE, SILICONE, AND ACRYLIC ADHESIVE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192128 SAFESTEP HUBER NEEDLE SET 20G X 1 IN SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS N/A UNK 00801741066221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other