BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURFLASH PLUS SAFETY IV CATHETER

    MDR report key: 4192382 · Received October 22, 2014

    Report

    Report Number
    9681835-2014-00025
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 22, 2014
    Manufacturer
    TERUMO CORPORATION - KOFU
    Product Code
    FOZ
    PMA / PMN Number
    K123267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS RETURNED AND EVALUATED. VISUAL INSPECTION CONFIRMED THAT THE SAFETY COVER ACTIVATED AND COVERED THE TIP OF THE INNER NEEDLE NORMALLY. THE FINGER GRIP WAS VISUALLY INSPECTED AND CONFIRMED THERE WERE NO ANOMALIES OR DEFORMATIONS THAT WOULD CAUSE THE SAFETY COVER TO NOT ACTIVATE. NO DEFORMATIONS WERE FOUND AT THE JUNCTION OF THE TIP OF THE SAFETY COVER AND FINGER GRIP AREA. REPRODUCTIVE TESTING WAS CONDUCTED BY ACTIVATING THE CATHETER OF A RETENTION SAMPLE. THE CATHETER ADVANCED SMOOTHLY AND THE COVER SHIELDED THE INNER NEEDLE NORMALLY. A REVIEW OF THE DEVICE HISTORY AND INSPECTION RECORDS INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. USER FACILITY INFORMATION AND THE EVALUATION RESULTS SUGGEST THAT THE ACTUAL DEVICE MAY HAVE BEEN GRASPED AT THE JUNCTION OF THE HUB AND THE TIP OF THE SAFETY MECHANISM WHICH WOULD PREVENT THE CATHETER FROM ADVANCING PROPERLY. DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE BY STATEMENTS SUCH AS, (1) "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" AND (2) DO NOT GRASP AT THE JUNCTION OF HUB AND TIP OF THE SAFETY MECHANISM TO DISCONNECT." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE CATHETER DID NOT ADVANCE WHEN USING A SURFLASH PLUS SAFETY IV CATHETER DURING A PROCEDURE. AFTER THE PUNCTURE, THE CATHETER HAD TO BE FORCEFULLY REMOVED FROM THE SAFETY COVER, AND THE TIP OF THE INNER NEEDLE WAS NOT PROPERLY SHIELDED. REPORTEDLY THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672396 SURFLASH PLUS SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ TERUMO CORPORATION - KOFU NA 140404K

    Patients

    Seq Age Sex Outcome Treatment
    1