BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURFLASH PLUS SAFETY IV CATHETER

    MDR report key: 3844706 · Received June 3, 2014

    Report

    Report Number
    9681835-2014-00015
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 3, 2014
    Manufacturer
    TERUMO CORPORATION - KOFU
    Product Code
    FOZ
    PMA / PMN Number
    K123267
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SECTION WAS COMPLETED BY THE MANUFACTURER PER CFR 803.52(F) BECAUSE THE INFORMATION WAS NOT INITIALLY COMPLETED BY THE USER FACILITY. THE INVOLVED DEVICE WAS RETURNED AND EVALUATED. IT WAS NOTED THAT THE SAFETY COVER WAS ENGAGED ON THE NEEDLE TIP UPON RECEIPT BY THE MANUFACTURING FACILITY. VISUAL INSPECTION CONFIRMED THAT THERE WERE NO PHYSICAL DEFECTS, DEFORMATIONS OR ANOMALIES ON THE ACTUAL SAMPLE INCLUDING THE SAFETY COVER. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THERE WAS NO PRODUCT OR MANUFACTURING RELATED ANOMALIES. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN PREVIOUSLY REPORTED. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THE EVENT DESCRIPTION AND APPEARANCE OF THE RETURNED SAMPLE INDICATE THAT THE HUB OF THE CATHETER WAS DETACHED FROM THE TIP OF THE SAFETY COVER BEFORE THE SAFETY COVER SHIELDED THE TIP OF THE INNER NEEDLE. IN THIS CASE, THE SAFETY COVER MIGHT NOT SHIELD THE TIP OF THE INNER NEEDLE IF THE JUNCTION OF THE HUB AND TIP OF THE SAFETY MECHANISM WERE GRASPED TO DISCONNECT THE DEVICE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE BY STATEMENTS INCLUDING: "WITH DOMINANT HAND GRASP AT FINGER GRIP AND PULL NEEDLE IN A STRAIGHT OUTWARD MOTION UNTIL NEEDLE TIP IS COMPLETELY SHIELDED BY THE SAFETY COVER AND AUTOMATICALLY DETACHES FROM HUB." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A NURSE INCURRED A NEEDLE STICK AFTER HAVING DIFFICULTY WITHDRAWING THE INNER NEEDLE FROM A SURFLASH PLUS SAFETY I.V. CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: (1) THE NURSE PULLED ON THE INNER NEEDLE AND IT DETACHED FROM THE HUB OF THE CATHETER RESULTING IN A NEEDLE STICK; (2) REPORTEDLY, THE SAFETY COVER DID NOT SHIELD THE TIP OF THE INNER NEEDLE BUT THEN ACTIVATED AFTER THE NEEDLE STICK OCCURRED; (3) THE NURSE UNDERWENT DIAGNOSTIC TESTING, HOWEVER THE RESULTS ARE NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325042 SURFLASH PLUS SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ TERUMO CORPORATION - KOFU NA 131129K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention