BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET

    MDR report key: 7142783 · Received December 22, 2017

    Report

    Report Number
    9616066-2017-01600
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Report Date
    November 29, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT THAT THE FEMALE LUER CRACKED AND LEAKED WAS CONFIRMED. VISUAL INSPECTION OF THE SET NOTED THE FEMALE LUER HAD A 0.618" VERTICAL HAIR LINE CRACK ON THE KNIT LINE OPPOSITE THE GATE. THE FEMALE LUER WAS INSPECTED UNDER MAGNIFICATION AND NO STRESS MARKS WERE OBSERVED. FURTHER VISUAL INSPECTION BY THE SUPPLIER CONFIRMED THAT THE CRACK IN THE LUER IS AN ISSUE WITH THE MANUFACTURING PROCESS OF THE FEMALE LUER COMPONENT WHICH IS MANUFACTURED BY A THIRD PARTY SUPPLIER. FUNCTIONAL TESTING CONFIRMED LEAKING AS FLUID FLOWED THROUGH THE CRACK ON THE FEMALE LUER. THE CAUSE OF THE LEAK WAS IDENTIFIED AS A CRACK ON THE FEMALE LUER. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    MW#5073184. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A MORPHINE INFUSION THE TUBING WAS OBSERVED TO BE CRACKED AND LEAKING AT THE CONNECTION BETWEEN THE NEEDLELESS CONNECTOR AND THE SYRINGE. NO PATIENT HARM WAS REPORTED, AND THE TUBING WAS CHANGED. RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM THE FDA WHICH STATES, "FIRST INSTANCE, MORPHINE DRIP WAS FOUND BY BEDSIDE NURSE LEAKING. TUBING WAS CRACKED AT THE MAXZERO CONNECTED TO THE SYRINGE. LINE WAS CHANGED PER PROTOCOL BY LT IMMEDIATELY. SECOND INSTANCE ALARIS (CAREFUSION) MICROBORE EXTENSION SET TUBING WITH 0.2 MICRON LOW PROTEIN BINDING FILTER (PRODUCT REF# (B)(4) WITH CRACK AT FEMALE END. THIS WAS CONNECTED TO A NEEDLELESS CONNECTOR (MAXZERO). NOT ABLE TO ISOLATE A LOT NUMBER FOR THIS VAROOM. THIS IS NOW THE THIRD PRODUCT FOUND CRACKED IN THE SAME PLACE. SEE VAROOM #S (B)(4) 2017. BOTH ON (B)(6) 2017. ALL 3 PRODUCTS WILL BE GIVEN TO RISK MGMT FOR F/U WITH COMPANY. PLEASE SEND REPORT FROM COMPANY WHEN THEY ARE FINISHED WITH THEIR INVESTIGATION. NO HARM TO DONE TO PT. MILRINONE WAS INFUSING VIA THIS TUBING FOR THIS PT. TUBING WAS IN-LINE APPROX. 24HRS BEFORE ONTO MEDFUSION PUMP AND FLOOR WAS NOTED. THIRD INSTANCE, BEDSIDE NOTICED VECURONIUM DRIP TUBING CRACKED AT THE MAXZERO CONNECTING TO THE SYRINGE. LINE CHANGED IMMEDIATELY BY LT." ALTHOUGH THE CUSTOMER SELECTED , "OTHER SERIOUS" ON THE MEDWATCH, THE CLINICIAN LATER CLARIFIED THAT NO MEDICAL INTERVENTION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922760 MICROBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION 10010570

    Patients

    Seq Age Sex Outcome Treatment
    1