BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL

    MDR report key: 3915192 · Received May 16, 2014

    Report

    Report Number
    9615050-2014-03484
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 18, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K103344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT: USER FACILITY VOLUNTARY MEDWATCH WAS RECEIVED ON (B)(4) 2014. THE REPORT NUMBER IS MW5035200. ONE OPENED SAMPLE WAS RECEIVED AND EVALUATED. THE DEVICE PASSED TESTING. NO LEAKS WERE NOTED DURING THE TESTING PROCEDURES. BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. 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 PROPOFOL 10MG/ML, AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE NURSE NOTED A MINIMAL AMOUNT OF SOLUTION LEAKED FROM THE AIR FILTER VENT ON THE PIERCING PIN OF THE TUBING SET ONTO THE FLOOR. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293532 PRIM SYM SET 2 CL 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK