BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MW5074250

    MDR report key: 7147685 · Received December 26, 2017

    Report

    Report Number
    MW5074250
    Event Type
    Malfunction
    Date Received
    December 26, 2017
    Date of Event
    December 4, 2017
    Report Date
    December 22, 2017
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE ISSUE WE ARE SEEING IS THAT THE TIP (BEVEL) IS BENT SLIGHTLY BACKWARDS AND MAY BE CAUSING A BACK WALL OF THE VEIN WHEN USED BY THE CLINICIAN TO START IV'S. THIS ONLY APPEARS TO BE HAPPENING WITH CERTAIN IV CATHETERS WITHIN THE SAME LOT. WE USE A B BRAUN 20G IV CATHETER , ITEM #4251652-02. WE HAVE IDENTIFIED DEFECTIVE NEEDLES WITH LOT #S ENDING IN 8301. HERE IS WHAT LOTS WE ARE EXPERIENCING THIS ON: 17K04G8301, 17E03G8301, 17G18G8301, 17A11G8301, AND 16N16G8301.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other