BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURFLASH PLUS SAFETY IV CATHETER

    MDR report key: 3852939 · Received June 6, 2014

    Report

    Report Number
    9681835-2014-00016
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 6, 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

    DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE WITH STATEMENTS SUCH AS, "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."

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE QUALITY RECORDS FOR THE LAST 6 MONTHS OF PRODUCTION WERE REVIEWED, AND IT WAS CONFIRMED THERE WERE NO PRODUCTION RELATED PROBLEMS NOR WERE THERE ANY COMPLAINTS RELATED TO THE PRODUCT OR PROCESS. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, USER FACILITY INFORMATION INDICATES 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. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR TRACKING, TRENDING, AND FOLLOW UP. (B)(4). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT #2 IS BEING SUBMITTED TO PROVIDE THE DATE THE MANUFACTURING FACILITY RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT AND/OR EVALUATION OF THE ACTUAL SAMPLE. THIS DATE WAS INADVERTENTLY OMITTED IN THE PREVIOUS FOLLOW-UP REPORT. THE INFORMATION PROVIDED BELOW LISTS THE DATE(S) THE ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURING FACILITY: FOLLOW-UP #1 = 06/06/2014.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #2 FOR MFG. REPORT #9681835-2014-00016 TO PROVIDE THE DATE THAT ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #1 FOR MFG. REPORT # 9681835-2014-00016 TO PROVIDE ADDITIONAL INFORMATION REGARDING APPLICABLE INSTRUCTIONS-FOR-USE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE SAFETY COVER DID NOT SHIELD THE TIP OF THE NEEDLE AFTER USING A SURFLASH PLUS SAFETY I.V. CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE NURSE HAD DIFFICULTY WITHDRAWING THE INNER NEEDLE; THE SAFETY COVER WAS GRASPED PROHIBITING THE CATHETER FROM ADVANCING; CONTINUAL PULLING CAUSED THE CATHETER TO DETACH FROM THE HUB PREVENTING PROPER SAFETY PROTECTION OF THE INNER NEEDLE; THERE WAS NO HARM TO THE PATIENT OR MEDICAL STAFF AS A RESULT OF THIS EVENT AND NO NEEDLE STICK OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331180 SURFLASH PLUS SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ TERUMO CORPORATION - KOFU NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1