BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTION PLUS IV CATHETER 226 1" #2000-06

    MDR report key: 122781 · Received September 18, 1997

    Report

    Report Number
    MW1012176
    Event Type
    Injury
    Date Received
    September 18, 1997
    Date of Event
    September 9, 1997
    Report Date
    September 9, 1997
    Manufacturer
    JOHNSON & JOHNSON MEDICAL INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IV ACCESS ATTEMPTED IN PT'S LEFT FOREARM BY NURSE VEIN ENTERED AND BLOOD RETURN OBTAINED. DREW BACK ON NEEDLE TO LOCK NEEDLE WITHIN SAFETY COVER. BLUE PLASTIC PIECE NOTICED JUST LYING ON PT'S ARM. COULDN'T SEE CLEAR PLASTIC CATHETER. THOUGHT IT MIGHT HAVE BECOME DISLODGED FROM BLUE PLASTIC HUB THAT WAS LYING LOOSE. IMMEDIATELY APPLIED PRESSURE TO ARM ABOVE IV SITE TO PREVENT POSSIBLE MIGRATION. CATHETER NOT VISUALIZED ON MULTIPLE XRAYS AND NOT FOUND ON OPEN EXPLORATION BY SURGEON. INSPECTION OF IV PACKAGE, CATHETER (LACK OF) NEEDLE AND ALL PIECES LEAD RPTR TO CONCLUDE THAT HUB WAS ALREADY BROKEN AND CATHETER ABSENT TO START WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTION PLUS IV CATHETER 226 1" #2000-06 IV CATHETER FOZ JOHNSON & JOHNSON MEDICAL INC. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention OPEN EXPLORATION OF LEFT ARM BY