BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET PP YSTE 272CM NDEHP

    MDR report key: 3413585 · Received September 25, 2013

    Report

    Report Number
    9615050-2013-03296
    Event Type
    Malfunction
    Date Received
    September 25, 2013
    Date of Event
    August 23, 2013
    Report Date
    August 26, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WERE DISCARDED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K982159. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DEVICE BREAKAGE. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS, AT UNSPECIFIED RATES. AT UNSPECIFIED TIMES, THE CUSTOMER CONTACT REPORTED THAT WHEN THE MALE ADAPTER OF UNSPECIFIED 50ML SYRINGES WERE CONNECTED TO THE SECONDARY PORT ON THE CASSETTE OF THE TUBING SETS, THE THREAD OF THE SYRINGES BROKE IN THE SECONDARY PORT ON THE CASSETTE OF THE TUBING SETS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED INCLUDING IF THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485889 PRIMARY PLUMSET PP YSTE 272CM NDEHP UNK FPA HOSPIRA COSTA RICA LTD NA 271125H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED 50ML SYRINGES, MFR UNK