BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL CATHETER

    MDR report key: 1013882 · Received March 14, 2008

    Report

    Report Number
    6000030-2008-01295
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT BEGAN EXPERIENCING DROWSINESS AND LETHARGY DUE TO A SUSPECTED OVERDOSE FOLLOWING PUMP REPLACEMENT. THE HCP WAS HAVING PROBLEMS ASPIRATING THE CATHETER, SO AN ATTEMPT WAS MADE TO PUSH FLUID THROUGH THE CATHETER AND IT WENT THROUGH, LIKELY GIVING THE PATIENT A BOLUS. THE PUMP WAS STOPPED AND THE PATIENT WAS TREATED WITH NARCAN FOR THE OVERDOSE. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMAL CATHETER LKK RICE CREEK MFG 8596 N135040024

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R IMPLANTABLE INFUSION PUMP MODEL 8637| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER MODEL 8709 LOT# L78001| LOT# NGP315910H| PROGRAMMER MODEL 8840 LOT# UNK