BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMBSET 2 CLAVES 272CM NDEHP

    MDR report key: 3960615 · Received June 20, 2014

    Report

    Report Number
    9615050-2014-04097
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 27, 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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED LEAK WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. 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 LEAK. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION, AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME, AN UNSPECIFIED 50ML SYRINGE CONNECTED TO A CLOSED SYSTEM DRUG TRANSFER DEVICE WAS CONNECTED TO THE CLAVE Y-SITE OF THE TUBING SET FOR THE DELIVERY OF AN UNSPECIFIED CONCENTRATION OF CYCLOPHOSPHAMIDE, VIA SYRINGE. THE CUSTOMER CONTACT REPORTED THAT APPROXIMATELY 40ML OF CYCLOPHOSPHAMIDE WAS DELIVERED. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE SYRINGE WAS DISCONNECTED FORM THE CLAVE Y-SITE. NO SPECIFIC DETAILS WERE PROVIDED AT THIS TIME, IT WAS REPORTED THAT APPROXIMATELY 5ML OF SOLUTION SPLASHED BACK ONTO THE STAFF. THE CUSTOMER CONTACT INDICATED THAT LOCAL POLICY WAS ADHERED TO. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PT OR HEALTHCARE PROVIDER AND NO REPORTED DELAY IN THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363556 PRIMARY PLUMBSET 2 CLAVES 272CM NDEHP UNK FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR UNSPECIFIED 50ML SYRINGE, MFR BY B. BRAUN, INC.| MFR BECTON DICKINSON AND CO| UNSPECIFIED PHASEAL CLOSED SYSTEM TRANSFER DEVICE