BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIAGATA SLIM-CATH DIALYSIS 12F X 12.5CM PRE-CURVED ST

    MDR report key: 3963271 · Received June 19, 2014

    Report

    Report Number
    3006260740-2014-00320
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MPB
    PMA / PMN Number
    K010778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONFIRMED AND WILL BE RECORDED AS USER RELATED. UPON RECEIPT OF THE COMPLAINT SAMPLE AT BAS THE DAMAGED GUIDEWIRE RESIDES WITHIN ITS PLASTIC HOOPED TRIGGER DISPENSER. THE DAMAGED INCURRED TO THE GUIDEWIRE EXHIBITS TENSIDE ELONGATION OF THE OUTER COILS AND SEPARATION OF THE CENTER CORE WIRE FROM ITS DISTAL WELD TIP. THE STRETCHED AND ELONGATED GUIDEWIRE HAS OCCURRED DURING THE INSERTION PROCEDURE. AS EVIDENCED BY THE SAMPLE RETURNED THE GUIDEWIRE HAS BEEN DAMAGED TROUGH USE. THE PRODUCT INSTRUCTIONS FOR USE (IFU) CAUTION THE USER, "IF THE GUIDEWIRE MUST BE WITHDRAWN WHILE THE NEEDLE IS INSERTED, REMOVE BOTH THE NEEDLE AND THE WIRE AS A UNIT TO PREVENT THE NEEDLE FROM DAMAGING OF SHEARING THE GUIDEWIRE." THE INTRODUCER NEEDLE WAS NOT RETURNED FOR EVAL. IN ADDITION TO, IF UNUSUAL RESISTANCE IS MET DURING MANIPULATION OF THE GUIDEWIRE, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. THIS MAY BE A USER TECHNIQUE ISSUE. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ROUTINE DIALYSIS OF THE OUTPATIENT, WHO HAD RECEIVED CATHETERIZATION IN THE RIGHT INTERNAL JUGULAR VEIN ON APRIL 17, SHOWED THAT THE GUIDE WIRE KINKED AND COULD NOT BE IMPLANTED, THEN REPORTED TO THE DEALER: IMPLANTATION PATH: CATHETERIZATION IN THE RIGHT INTERNAL JUGULAR VEIN; THE RESULT OF EVENTS AND THE PT'S CONDITION (BLEEDING, NEW CATHETER REPLACEMENT, THERAPY DATE, NO ABNORMALITIES, ETC). THE PT HAD NO ABNORMALITIES AT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359629 HIAGATA SLIM-CATH DIALYSIS 12F X 12.5CM PRE-CURVED ST MPB BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR