BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBORE PRESSURE, IV CONNECTOR NO CLAMP

    MDR report key: 7771105 · Received August 9, 2018

    Report

    Report Number
    9616066-2018-01328
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 13, 2018
    Report Date
    July 18, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403230196
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF A LEAK AT THE CONNECTION WAS NOT CONFIRMED. VISUAL INSPECTION SHOWED NO ANOMALIES. FUNCTIONAL TESTING SHOWED NO ANOMALIES. THE ROOT CAUSE OF THE CUSTOMER'S REPORT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THIS OCCURRED IN THE NEONATAL INTENSIVE CARE UNIT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT PGE LEAKED AT THE CONNECTION OF THE "PIGTAIL" EXTENSION SET TO THE TUBING DURING AN INFUSION. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT PGE LEAKED AT THE CONNECTION OF THE "PIGTAIL" EXTENSION SET TO THE TUBING DURING AN INFUSION IN THE NICU. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT PGE LEAKED AT THE CONNECTION OF THE "PIGTAIL" EXTENSION SET TO THE TUBING DURING AN INFUSION IN THE NICU. THERE WAS NO REPORT OF PATIENT HARM.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE EXTENSION SET WAS NOTED TO BE LEAKING AT THE PIGTAIL WHERE IT CONNECTS TO THE TUBING WHILE CONNECTED TO A PATIENT. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PGE LEAKED AT THE CONNECTION OF THE "PIGTAIL" EXTENSION SET TO THE TUBING DURING AN INFUSION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611338 MINIBORE PRESSURE, IV CONNECTOR NO CLAMP SET,ADMINISTRATION,INTRAVASCULAR FPA CAREFUSION MZ5306 10885403230196

    Patients

    Seq Age Sex Outcome Treatment
    1 MZ1000-07, TD (B)(6) 2018| MZ9226| PRI TUBING,MZ5306, PGE SYRINGE, TD (B)(6) 2018