BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J011RO JOEY ADAPUTER TYPE X30

    MDR report key: 10537442 · Received September 15, 2020

    Report

    Report Number
    8040459-2020-00540
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    September 4, 2020
    Report Date
    March 12, 2021
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. ONE USED DEVICE IN AN OPENED PACKAGE WAS RETURNED FOR EVALUATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED; A CRACK WAS FOUND ON THE KPS CONNECTOR OF THE PUMP SET. THE AFF VALVE WAS ALSO FOUND TO NOT BE SET IN THE NORMAL POSITION WHICH INDICATES THE PRODUCT WAS PRIMED PRIOR TO USE. SINCE THE CUSTOMER DID NOT NOTICE THE ABNORMALITIES DURING THE PRIMING PROCESS WITH THE FEEDING PUMP AND THE PRE-CHECK DID NOT IDENTIFY THE CONNECTOR DAMAGED, THERE IS INDICATION THAT THE PRODUCT WAS FUNCTIONING AS INTENDED PRIOR TO USE. BASED ON THE AVAILABLE INFORMATION, THE REPORTED CONDITION WAS NOT DETERMINED TO BE RELATED TO THE MANUFACTURING PROCESS THEREFORE NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS INVESTIGATION WILL BE UPDATED AS NEEDED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    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 CUSTOMER REPORTED THAT THE ENTERAL FEEDING SET WAS LEAKING. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000585 J011RO JOEY ADAPUTER TYPE X30 PUMP, INFUSION, ENTERAL LZH COVIDIEN J011RO 2001505FJY

    Patients

    Seq Age Sex Outcome Treatment
    1