BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM SITE CHBR W/BALL PP YSTE 264CM NDHP

    MDR report key: 3128773 · Received May 22, 2013

    Report

    Report Number
    9615050-2013-01354
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 24, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF (B)(4) AND HAS A 510K OF K052052. THIS REPORT REPRESENTS ALL THE INFORMATION 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 LEAKS. ON UNSPECIFIED DATES, THE TUBING SETS WERE BEING USED TO DELIVER EITHER UNSPECIFIED VOLUMES OF NORMAL SALINE OR UNSPECIFIED CHEMOTHERAPEUTIC AGENTS. AFTER UNSPECIFIED LENGTHS OF TIME, THE CUSTOMER CONTACT REPORTED THAT UNSPECIFIED VOLUMES OF SOLUTION LEAKED FROM THE AIR VENT ON THE PIERCING PIN OF THE TUBING SETS. IT WAS REPORTED THAT THE NURSES SEALED THE AIR VENT WITH CLINICAL TAPE AND THE THERAPIES WERE COMPLETED. THE SOLUTION THAT LEAKED WERE CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS IN CRITICAL THERAPIES TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226480 PLUM SITE CHBR W/BALL PP YSTE 264CM NDHP UNK FPA HOSPIRA COSTA RICA LTD. NA 232085H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK