BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET 2 CLAVES 272CM NDEHP

    MDR report key: 3881095 · Received April 7, 2014

    Report

    Report Number
    9615050-2014-02541
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 13, 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 INDICATED THE DEVICE WAS 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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE SILICONE SLEEVE OF THE CLAVE PORT REMAINED IN THE DEPRESSED POSITION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF SALINE SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME, THE MALE ADAPTER OF AN UNSPECIFIED 50ML SYRINGE WAS CONNECTED VIA A PHASEAL DEVICE TO THE CLAVE Y-SITE OF THE TUBING SET FOR THE DELIVERY OF AN UNSPECIFIED VOLUME OF EITHER DOXORUBICIN OR CYCLOPHOSPHAMIDE, VIA IV PUSH. THE CUSTOMER CONTACT REPORTED THAT AFTER THE NURSE DISCONNECTED THE SYRINGE FROM THE CLAVE Y-SITE LESS THAN 1ML OF SOLUTION SQUIRTED BACK ONTO THE DISPOSABLE APRON OF THE NURSE. IT WAS REPORTED THAT THE SILICONE SLEEVE OF THE CLAVE Y-SITE REMAINED IN THE DEPRESSED POSITION. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL AND THE DISPOSABLE APRON WAS DISCARDED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS OR DELAY IN THERAPY CRITICAL TO THIS PT OR TO THE NURSE. NO MEDICAL INTERVENTION WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209689 PRIMARY PLUMSET 2 CLAVES 272CM NDEHP UNK FRN HOSPIRA COSTA RICA LTD. NA 334505H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PHASEAL SYSTEM: PRODUCT CODE UNK, MFG: BAXTER INC.| UNSPECIFIED 50ML SYRINGE, MFG UNK