BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD MICRO INTRODUCER KIT

    MDR report key: 2082172 · Received April 28, 2011

    Report

    Report Number
    1319211-2011-00042
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    February 17, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    PMA / PMN Number
    K080400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MFR FOR EVAL. AN INVESTIGATION INTO THE ROOT CAUSE FOR THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A F/U MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER ON (B)(6) 2011, DURING A PIC CATHETER PLACEMENT ON (B)(6) 2011, THE MICRO INTRODUCER WIRE BECAME UNRAVELED WHILE IN USE. THE TIP OF THE WIRE BECAME STUCK INSIDE THE PT AND THE PHYSICIAN WHO PERFORMED THE PICC PLACEMENT USED A SNARE TO SUCCESSFULLY RETRIEVE THE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ISSUES. NO HARM OR INJURY WAS REPORTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD MICRO INTRODUCER KIT GUIDEWIRE MSD ANGIODYNAMICS NA NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention