BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANT OCCL FCPS ST 4-1/2

    MDR report key: 2201276 · Received August 3, 2011

    Report

    Report Number
    2523190-2011-00053
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    INTEGRA, YORK - IMILTEX
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTED THE ITEM IS TOO HARD TO OPEN. ONCE CLAMPED SHUT THEY ARE SO TIGHT THEY DAMAGE THE TUBING. ON (B)(6) 2011, CUSTOMER E-MAIL REPORTS THESE CLAMPS ARE PRIMARILY USED FOR OCCLUDING TUBING BEFORE BEING ATTACHED TO THE PT. CLAMPS ARE USED TO OCCLUDE THE TUBING WHEN ATTACHING HEPARIN SYRINGE TO DIALYSIS MACHINE TUBING. USER FOUND ALL CLAMPS DIFFICULT TO OPEN, SOME WOULD NOT OPEN. KINK (GROOVE IMPRESSION) FOUND IN THE TUBING WHEN CLAMPED FOR LESS THAN ONE MINUTE. CUSTOMER SEES POTENTIAL FOR HARM OF CUTTING THE TUBING BECAUSE CLAMPS HAVE SHARP EDGES. THESE FORCEPS ARE ALSO LEFT AT THE BEDSITE TO BE USED IN CASE OF EMERGENCY TO CLAMP THE TUBING. FORTUNATELY, THERE WAS NO SUCH EMERGENCY DURING THE USE OF THESE CLAMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANT OCCL FCPS ST 4-1/2 M5 - GENERAL SURGERY LRW INTEGRA, YORK - IMILTEX

    Patients

    Seq Age Sex Outcome Treatment
    1