BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTED PERCUTANEOUS CATHETER

    MDR report key: 8926975 · Received August 23, 2019

    Report

    Report Number
    3006260740-2019-02481
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Report Date
    August 23, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE; AS NO MANUFACTURING LOT NUMBER(S) HAS BEEN PROVIDED. PER 21 CFR PART 803.56 NOT ENOUGH INFORMATION HAS BEEN PROVIDED ABOUT EACH IDENTIFIED PATIENT AND/OR DEVICE MENTIONED. THEREFORE, ONE EMDR IS BEING SUBMITTED FOR MULTIPLE REPORTABLE EVENTS, IDENTIFIED IN THE LITERATURE SEARCH.

    Description of Event or Problem · 1

    PER ELSEVIER INC. STUDY: "2 OUT OF 51 DEMONSTRATED A MALPOSITIONED CATHETER. ONE CATHETER WAS IN THE PROXIMAL SUPERIOR VENA CAVA/BRACHIOCEPHALIC JUNCTION. THE LINE WAS USED AS IS. ONE CATHETER IN THE RIGHT ATRIUM AT A DEPTH OF 1 CM. THE LINE WAS RETRACTED BY THE PRIMARY SERVICE AND REQUIRED A SUBSEQUENT CHEST RADIOGRAPH, THIS LINE DID NOT REQUIRE REPOSITIONING. (P. 98). REFERENCE: BEDSIDE PERIPHERALLY INSERTED CENTRAL CATHETER TIP CONFIRMATION: A DIRECT SAVINGS ANALYSIS SANJAY A. PATEL, MD, POUSHALI BHATTACHARJEE, MD, MS, LATOYIA ROMAN, RN, FNP - ELSEVIER INC. ASSOCIATION FOR VASCULAR ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722119 IMPLANTED PERCUTANEOUS CATHETER CATHETER, PERCUTANEOUS LJS BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1