BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORPHEUS PICC

    MDR report key: 3974858 · Received June 11, 2014

    Report

    Report Number
    1319211-2014-00086
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    November 8, 2013
    Report Date
    May 30, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    PMA / PMN Number
    K030415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL REPORTED COMPLAINT DESCRIPTION WAS FOR LEAKING EXTENSION TUBING, WHICH DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT. RETURNED FOR EVALUATION WAS A USED 5F DUAL LUMEN MORPHEUS PICC. A VISUAL EVALUATION OF THE RETURNED DEVICE NOTED NO DEFECTS. FUNCTIONAL TESTING WAS PERFORMED ON THE DEVICE, WHICH REVEALED A SMALL HOLE IN THE CATHETER SHAFT. THIS DEFECT MEETS THE CRITERIA OF A REPORTABLE EVENT. THE REPORTED COMPLAINT DESCRIPTION FOR THE EXTENSION TUBING LEAK CANNOT BE CONFIRMED, HOWEVER, THE DEVICE DID CONTAIN A DEFECT. DURING MANUFACTURING AND PRIOR TO PACKAGING, EACH CATHETER IS 100% LEAK TESTED AND VISUALLY INSPECTED FOR DIGS, CUTS, KINKS ON THE CATHETER SHAFT. THE ROOT CAUSE FOR THE COMPLAINT DESCRIPTION CANNOT BE DEFINITIVELY DETERMINED, HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    AS ORIGINALLY REPORTED ON (B)(6) 2013, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR PICC PLACEMENT PROCEDURE. POST PROCEDURE, IT WAS REPORTED THE EXTENSION LEGS WERE LEAKING WHERE THE HUBS WERE BONDED TO THE EXTENSION TUBING. THE PICC WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. DURING THE DEVICE EVALUATION ON (B)(4) 2014, IT WAS NOTED THE REPORTED DEFECT DESCRIPTION WAS NOT LEAKING EXTENSION TUBING, BUT A SMALL HOLE IN THE CATHETER SHAFT. IT WAS REPORTED THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THE EVENT. THE REPORTED DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343827 MORPHEUS PICC PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS 583802

    Patients

    Seq Age Sex Outcome Treatment
    1