BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECT SFTY SCREW SPIKE NS

    MDR report key: 11016483 · Received December 16, 2020

    Report

    Report Number
    1282497-2020-09792
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    October 31, 2020
    Report Date
    December 15, 2020
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    UDI-DI
    10884521190818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.  AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.  IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE PATIENT'S HUSBAND REPORTED THAT THERE WAS AIR IN THE TUBING BETWEEN THE BOTTLE AND THE PUMP DURING FEEDING. THE CUSTOMER CHANGED THE SET AND EVEN THOUGH THE DEBIT WAS SET TO 90ML/HR AND VOLUME AT 850ML, AFTER 6HR ONLY 225ML WAS ADMINISTERED (BASED ON THE AMOUNT LEFT IN THE BOTTLE). THE PATIENT IS FED OVERNIGHT (9PM-6:25AM) FOR A TOTAL OF 9H25MIN AT 90ML/HR AND A VOLUME OF 850ML. THE PATIENT IS FED TWOCAL HN B J-TUBE. THE PATIENT WAS NOT OVER/UNDER FED. THE FEEDING TOOK LONGER THE SECOND TIME THE SET WAS CHANGED BUT THE CUSTOMER DOES NOT REMEMBER HOW MUCH LONGER. THE SETS ARE CHANGED ON A DAILY BASIS. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480898 CONNECT SFTY SCREW SPIKE NS PUMP, INFUSION, ENTERAL LZH COVIDIEN 77000FD 182430149 10884521190818

    Patients

    Seq Age Sex Outcome Treatment
    1