BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP

    MDR report key: 8925840 · Received August 23, 2019

    Report

    Report Number
    3006575795-2019-00022
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    August 16, 2019
    Report Date
    September 5, 2019
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FPA
    UDI-DI
    00814371020570
    PMA / PMN Number
    K132841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING OF FIVE ADMINISTRATION SETS FROM THE SAME LOT RETURNED FROM THE CUSTOMER WAS PERFORMED BY THE SERVICE PROVIDER ON 09/05/2019. THE REPORTED LEAKING ISSUE COULDN'T BE REPEATED. ON VISUAL INSPECTION, NO ABNORMALITIES WERE OBSERVED ON THE FIVE SAMPLE IV SETS. DURING THE TESTING, NO LEAKING ISSUE WAS OBSERVED ANYWHERE ON THE FIVE SAMPLE IV SETS. THE COMPLAINT COULDN'T BE CONFIRMED.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2019-00022).

    Additional Manufacturer Narrative · 1

    ZYNO MEDICAL IS WAITING FOR THE ARRIVAL OF SAMPLES TO PERFORM THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2019, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A DISTRIBUTOR. THE DISTRIBUTOR STATED THAT A USER FACILITY REPRESENTATIVE REPORTED THAT "AN ADMINISTRATION SET MODEL BX-70072 LOT # 1810010 WAS LEAKING FROM THE BOTTOM JOINT OF THE DRIP CHAMBER". NO PATIENT HARM OR INJURY WAS INVOLVED. THE DEVICE OPERATOR WAS A RN. THE MEDICATION BEING INFUSED WAS IRON. THE USER FACILITY REPRESENTATIVE STATED THE AFFECTED SET HAD BEEN DISCARDED AND SHE WOULD SEND IN 5 SAMPLE SETS FROM THE SAME BOX AND LOT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720907 ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP IV ADMINISTRATION SET FPA ZYNO MEDICAL, LLC BX70072 1810010 00814371020570

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR