BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEGASUS¿ 24GA X 0.75IN PRN

    MDR report key: 5648054 · Received May 11, 2016

    Report

    Report Number
    3006948883-2016-00016
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    April 17, 2016
    Report Date
    April 28, 2016
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A SAMPLE WAS NOT RETURNED FOR EVALUATION BUT A PHOTO WAS RECEIVED. THE PHOTO REVEALS THE CANNULA HAS BEEN PULLED OUT AND THE CATHETER IS BROKEN. DUE TO THE QUALITY OF THE RETURNED PHOTO, THE STATUS OF THE BROKEN SECTION CANNOT BE CLEARLY VIEWED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5110032. AS THERE IS 100% OFFLINE INSPECTION IN MANUFACTURING PROCESS, WHICH PREVENTS DEFECTIVE PRODUCT TO BE RELEASED, THIS DEFECT HAS BEEN DETERMINED NOT TO BE MANUFACTURING RELATED. AS THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUSPECT DEVICE WAS INSERTED ON (B)(6) 2016. WHEN THE INFUSION WAS COMPLETE, THE PATIENT WAS SENT HOME WITH THE DEVICE IN PLACE. ON (B)(6) 2016 AT 11 PM, THE PATIENT'S PARENTS FOUND THE IV TO BE LOOSE AND DISCOVERED THE CATHETER BROKEN AND MISSING. THE PATIENT HAD AN X-RAY AND CT SCAN BUT NO ABNORMALITY WAS OBSERVED. ON (B)(6) 2016 AT 1 AM, THE BROKEN CATHETER PIECE WAS FOUND OUTSIDE OF THE BODY AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303457 BD PEGASUS¿ 24GA X 0.75IN PRN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 5110032

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention