BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW

    MDR report key: 7872565 · Received September 12, 2018

    Report

    Report Number
    MW5079773
    Event Type
    Injury
    Date Received
    September 12, 2018
    Date of Event
    August 30, 1988
    Report Date
    September 11, 2018
    Manufacturer
    TELEFLEX INC. / ARROW INTERNATIONAL, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EPIDURAL NEEDLE SLIGHTLY BENT AFTER CATHETER PLACEMENT. WHEN CATHETER WAS DISCONTINUED, THE TIP WAS NOT INTACT AND THERE WAS A HAIRLINE SPLIT AT THE CATHETER END. CT ON (B)(6) 2018 ALSO REVEALED THAT PT HAD "ADVANCED L5-S1 DEGENERATIVE DISC DISEASE WITH CHRONIC SMALL RIGHT PARACENTRAL DISC PROTRUSION RESULTING IN MID RIGHT CANAL STENOSIS AND MILD RIGHT LATERAL RECESS NARROWING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708657 ARROW FLEX TIP PLUS EPIDURAL KIT CAZ TELEFLEX INC. / ARROW INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention