BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    777501 JOEY ENPLUS SPIKE SET X30

    MDR report key: 15946186 · Received December 8, 2022

    Report

    Report Number
    9611018-2022-00570
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Report Date
    January 11, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION/D2A/D2B (PRODUCT CODE/ COMMON DEVICE NAME): ORIGINALLY REPORTED AS KNT - TUBES, GASTROINTESTINAL (AND ACCESSORIES) AND SHOULD BE LZH - PUMP, INFUSION, ENTERAL.

    Additional Manufacturer Narrative · 0

    SECTION B5 HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION. THE LOT NUMBER WAS PROVIDED, AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. PER CUSTOMER, THE SAMPLE WAS DISCARDED. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. WE WILL KEEP MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AIR ENTERED THE TUBING DURING ADMINISTRATION OF THE NUTRIENT WHEN THE PURGE HAS BEEN COMPLETED. THERE WAS NO HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE AIR BUBBLES APPEARED AFTER 2 TO 3 HOURS AFTER STARTING THE PUMP.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AIR ENTERED THE TUBING DURING ADMINISTRATION OF THE NUTRIENT WHEN THE PURGE HAS BEEN COMPLETED. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596579 777501 JOEY ENPLUS SPIKE SET X30 PUMP, INFUSION, ENTERAL LZH CARDINAL HEALTH 777501 22D211FHX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown