BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM

    MDR report key: 9597074 · Received January 16, 2020

    Report

    Report Number
    3006575795-2020-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 19, 2019
    Report Date
    May 14, 2020
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FPA
    UDI-DI
    00814371020525
    PMA / PMN Number
    K132841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZYNO MEDICAL LLC RECEIVED THE ADMINISTRATION SET EVALUATION REPORT FROM THE SERVICE PROVIDER ON 03/06/2020. THE ACTUAL DEVICE WAS TESTED. LEAKING WAS OBSERVED BETWEEN THE TUBING AND THE LUER LOCK ON THE ADMINISTRATION SET. THE REPORTED ISSUE WAS CONFIRMED. POSSIBLE ROOT CAUSE COULD BE INSUFFICIENT GLUE BETWEEN THE TUBING AND THE LUER LOCK.

    Additional Manufacturer Narrative · 0

    ZYNO MEDICAL SENT A QUALITY ALERT TO THE CONTRACT MANUFACTURER ON 03/18/2020. THE CONTRACT MANUFACTURER PROVIDED THE INVESTIGATION REPORT ON 05/14/2020. POSSIBLE ROOT CAUSES CAN BE: 1) POOR ADHESION BETWEEN THE TUBING AND THE LUER LOCK CONNECTOR; 2) DEFORMATION OF LUER LOCK CONNECTOR. 6 PIECES OF RETAINED SAMPLES FROM THE SAME LOT NUMBER WERE INSPECTED FOR ADHESIVE BONDING AND TUBING DIMENSION. NO ISSUE WAS IDENTIFIED AND THE SAMPLES MEET SPECIFICATIONS. INVESTIGATION AND ANALYSIS INDICATE THAT THE COMPLAINT SHOULD BE AN INDIVIDUAL CASE.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00001).

    Description of Event or Problem · 0

    THIS IS THE SECOND FOLLOW-UP FOR THE INITIALLY FILED MDR 3006575795-2020-00001.

    Additional Manufacturer Narrative · 1

    ZYNO MEDICAL IS WAITING FOR THE ARRIVAL OF THE AFFECTED DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR STATING THAT "AN ADMINISTRATION SET MODEL BX-70070, LOT NUMBER 1904010 HAD A LEAK." A PATIENT WAS INVOLVED, BUT THERE WAS NO HARM. THE DEVICE OPERATOR WAS A REGISTERED NURSE. THE MEDICATION BEING INFUSED WAS ERTAPENEM. THE DISTRIBUTOR ASKED THE USER FACILITY REPRESENTATIVE TO PROVIDE FURTHER INFORMATION ON WHERE THE LEAKING CAME FROM BUT THE USER FACILITY REPRENSENTATIVE COULD NOT SPECIFY ANY MORE INFORMATION. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO., LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59982 ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM IV ADMINISTRATION SET FPA ZYNO MEDICAL, LLC BX70070 1904010 00814371020525

    Patients

    Seq Age Sex Outcome Treatment
    1