BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 5388710 · Received January 25, 2016

    Report

    Report Number
    1219930-2016-00062
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Date of Event
    December 13, 2015
    Report Date
    January 7, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    LJS
    PMA / PMN Number
    K961856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV)CONCURRENTLY WITH ENGINEERING LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, AN ENGINEERING REVIEW, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE VISUAL INSPECTION OF THE DEVICE NOTED NO VISUAL ABNORMALITIES. ONE OBTURATOR WAS RECEIVED. ALL COMPONENTS WERE PRESENT AND INTACT. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SAMPLE CONFIRMED THE PRODUCT MET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITIONS. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SUBSEQUENTLY, THE COMPLAINT DATA DID NOT DISPLAY AN INCREASED TREND. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE RIGHT-ANGLE NON-CORING NEEDLE DESTROYED SILICONE SEPTUM FOR THE DOCTOR SAW A VERY TINY PIECE OF SILICONE (FALLEN ON THE GROUND, CAN'T BE FOUND) WHEN TESTING. THE DOCTOR COMPLAINED THE DESIGN OF NON-CORING NEEDLE WAS NOT REAL NON-CORING NEEDLE. FOR THIS REASON, THE DOCTOR THOUGHT THE IMPROPER DESIGN OF NON-CORING NEEDLE COULD CAUSE EXTRAVASATION AND HE DIDN'T WANT TO IMPLANT THE DAMAGED PORT ON THE PATIENT. THE DOCTOR ALSO MENTIONED THAT OUR PRODUCTS DIDN'T HAVE THIS PROBLEM BEFORE. IT WAS ALSO REPORTED THAT THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT AS A RESULT OF THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48002 2PC VSYS W/9FR INTR KIT LW PFL CATHETER INTRODUCER KIT LJS COVIDIEN, FORMERLY US SURGICAL A DIVISON 120021 N4L0500X

    Patients

    Seq Age Sex Outcome Treatment
    1