BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOEY 1000ML PUMP SET

    MDR report key: 11057270 · Received December 22, 2020

    Report

    Report Number
    1282497-2020-09807
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    December 16, 2020
    Report Date
    December 22, 2020
    Manufacturer
    COVIDIEN
    Product Code
    LZF
    UDI-DI
    10884521072305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED A HOME PATIENT EXPERIENCED KINKS IN THE TUBING AND AIR POCKETS PREVENTING THE FEED FROM DELIVERING. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524512 JOEY 1000ML PUMP SET PUMP, INFUSION, ANALYTICAL SAMPLING LZF COVIDIEN 763656 10884521072305

    Patients

    Seq Age Sex Outcome Treatment
    1