BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K 924 1000 ML PUMP SET INDIV.

    MDR report key: 6168225 · Received December 12, 2016

    Report

    Report Number
    1282497-2016-01015
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 28, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER SHOWS EVIDENCE THAT THE PRODUCT WAS RELEASED ACCORDING TO ALL ESTABLISHED PROCEDURES AND QA. THREE SAMPLES WERE RECEIVED FOR EVALUATION. THE SAMPLES WERE FUNCTIONALLY TESTED A LEAK WAS OBSERVED IN THE LEFT SIDE OF THE BOTTOM PART OF THE BAG, THE FAILURE MODE REPORTED IT WAS CONFIRMED. THE POSSIBLE ROOT CAUSE IS RELATED WITH THE SEALING PROCESS OF THE BAG. IT WAS IDENTIFIED THAT THE DIE USED WAS PF48, THIS DIE WAS REMOVED FROM THE PROCESS DUE TO IDENTIFYING SOME ISSUES DURING THE PROCESS. THE CORRECTIVE ACTIONS WERE ALREADY IMPLEMENTED AND A QUALITY ALERT WILL BE GENERATED FOR INFORM TO THE PERSONNEL ON PRODUCTION FLOOR. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. THE INITIAL WAS REPORTED VIA #1282497-2016-01015. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 12/12/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    ON (B)(6)2016, IT WAS REPORTED TO COVIDIEN THAT A CUSTOMER EXPERIENCED AN ISSUE WITH THREE ENTERAL FEEDING PUMP SETS. THE CUSTOMER REPORTS THAT THE BAGS BEGAN LEAKING. NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT AN ISSUE OCCURRED WITH ENTERAL FEEDING SETS. THE CUSTOMER REPORTS THAT THREE BAGS BEGAN LEAKING. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818742 K 924 1000 ML PUMP SET INDIV. ENTERAL FEEDING SETS KNT COVIDIEN 673622 151280128X

    Patients

    Seq Age Sex Outcome Treatment
    1