BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET 2 CLAVES 272CM NDEHP

    MDR report key: 4152570 · Received October 6, 2014

    Report

    Report Number
    9615050-2014-05487
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER. (B)(4). THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DEVICE BREAKAGE; SUBSEQUENTLY A LEAK WAS NOTED. THE PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED SYRINGE WAS CONNECTED AND TIGHTENED TO AN UNSPECIFIED CLAVE PORT OF THE TUBING SET FOR THE DELIVERY OF HYDROCORTISONE, VIA AN UNSPECIFIED ROUTE. AT THIS TIME, IT WAS REPORTED THAT THE FIXED PLASTIC JUST BELOW THE CLAVE SNAPPED ON ONE SIDE, LEAVING THE CLAVE STILL ATTACHED. IT WAS REPORTED THAT A CONSIDERABLE VOLUME OF SOLUTION LEAKED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622145 PRIMARY PLUMSET 2 CLAVES 272CM NDEHP UNK FRN HOSPIRA COSTA RICA LTD. NA 430525H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED 10ML SYRINGE, MFR UNK