BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO PROTECTIV

    MDR report key: 2072113 · Received April 13, 2011

    Report

    Report Number
    2072113
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 2, 2011
    Report Date
    April 13, 2011
    Manufacturer
    SMITHS MEDICAL ASD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    I INSERTED AN IV INTO THE PATIENT'S LEFT HAND. IT APPEARED TO BE A SUCCESSFUL STICK SO I SECURED THE HUB OF THE IV CATHETER AND ATTACHED THE FLUSH. I CHECKED AND SAW GOOD BLOOD RETURN, BUT WHEN I FLUSHED THE IV I NOTICED FLUID AND BLOOD LEAKING AT THE INSERTION SITE COMING FROM A TINY HOLE IN THE CATHETER WHERE IT ATTACHED TO THE PINK HUB. I HAD TO REMOVE THE CATHETER FROM THE PATIENT AND STICK THE PATIENT AGAIN. IN THIS CASE THE PATIENT HAD BEEN STUCK SEVERAL TIMES AND THIS WOULD HAVE BEEN A SUCCESS HAD THE IV CATHETER NOT BEEN A DEFECT.PATIENT SUSTAINED NO INJURIES AS A RESULT OF THE DEFECTIVE IV CATHETER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO PROTECTIV CATHETER, IV FOZ SMITHS MEDICAL ASD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR