BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH T

    MDR report key: 1655352 · Received April 2, 2010

    Report

    Report Number
    9613251-2010-00033
    Event Type
    Malfunction
    Date Received
    April 2, 2010
    Date of Event
    January 1, 2010
    Report Date
    March 11, 2010
    Manufacturer
    HOSPIRA 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 INDICATED THAT THE DEVICES WERE DISCARDED. REPRESENTATIVE DEVICES FROM THE SAME LOT ARE EXPECTED TO BE RETURNED FOR INVESTIGATION. THEY HAVE NOT YET BEEN PROVIDED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT IS COMPARABLE TO THE DOMESTIC LIST NUMBER IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A 80FPK COMMON DEVICE NAME AND HAS A 510K OF K063239. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF LEAKAGE OF CHEMOTHERAPEUTIC AGENTS. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED CHEMOTHERAPEUTIC AGENTS. THE MALE ADAPTERS OF THE TUBING SETS WERE CONNECTED TO THE PTS CATHETERS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE PTS REPORTED THAT THE CATHETER DRESSINGS WERE WET. AT THAT TIME, THE HEALTHCARE PROFESSIONALS NOTED THAT THE CHEMOTHERAPEUTIC AGENTS HAD LEAKED FROM THE CONNECTIONS OF THE MALE ADAPTERS AND THE CATHETERS. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THE SOLUTIONS THAT LEAKED WERE CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET WITH T UNK FPA HOSPIRA LTD. NA 74002NY

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)| UNSPECIFIED CATHETERS