BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN 9.6 FR SINGLE - LUMEN CV CATHETER, PEEL-APART INTRODUCER

    MDR report key: 3770071 · Received January 28, 2014

    Report

    Report Number
    3006260740-2014-00029
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 3, 2014
    Report Date
    January 6, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE NOTES IN THIS FILE, "CUFF WAS NOT INGROWN INTO TISSUE AND NURSE NOTICED THAT AFTER THE SUTURES WERE REMOVED, THE LINE WOULD BEGIN FALLING OUT." THIS COMPLAINT IS INCONCLUSIVE. UPON RECEIPT A SMALL AMOUNT OF RESIDUAL MATERIAL WAS OBSERVED EMBEDDED IN THE DACRON MATERIAL OF THE SURECUFF. NO DEFECTS WERE IDENTIFIED WITH THE SURECUFF AND THERE IS A COMPLETE BOND BETWEEN THE DACRON MATERIAL AND CATHETER TUBING. CATHETER DISLODGEMENT CAN OCCUR DUE TO A LACK OF COMPLETE TISSUE IN GROWTH AROUND THE SURECUFF. THIS MAY BE DUE TO THE PHYSIOLOGY OF THE PATIENT. PROPER DRESSING AND ANCHORING OF THE CATHETER WILL HELP PREVENT DISLODGEMENT. THE COMPLAINT FILE INDICATES THE DEVICE HAD BEEN IN USE FOR APPROXIMATELY 1 MONTH PRIOR TO THE COMPLAINT INCIDENT. THE PRODUCT INSTRUCTIONS FOR USE (IFU) GIVES GRAPHIC AND DESCRIPTIVE INFORMATION ON PROPER DRESSING TECHNIQUES. A LOT HISTORY REVIEW (LHR) IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER INFORMATION HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT CAME IN FOR HICKMAN INSERTION (B)(6) 2013 AND HAD SUTURES REMOVED ON (B)(6) 2014. CUFF WAS NOT INGROWN INTO TISSUE AND NURSE NOTICED THAT AFTER THE SUTURES WERE REMOVED, THE LINE WOULD BEGIN FALLING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61393 HICKMAN 9.6 FR SINGLE - LUMEN CV CATHETER, PEEL-APART INTRODUCER LJS C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention