BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET 7IN REM CLAVE SITE NDEHP

    MDR report key: 3113203 · Received May 8, 2013

    Report

    Report Number
    9613251-2013-00138
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 12, 2013
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICES WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. 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 THE SILICONE SLEEVE OF THE CLAVE PORT REMAINED IN THE DEPRESSED POSITION. ON AN UNSPECIFIED DATE, THE TUBING SET WAS BEING USED FOR AN INTERMITTENT DELIVERY OF UNSPECIFIED MEDICATIONS VIA IV PUSH. THE SECURE-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PATIENT'S IV ACCESS SITE. AT AN UNSPECIFIED TIME, THE CUSTOMER CONTACT REPORTED THAT THE MALE ADAPTER OF AN UNSPECIFIED SYRINGE WAS CONNECTED TO THE CLAVE PORT OF THE TUBING SET FOR DELIVERY OF 10ML OF NORMAL SALINE VIA IV PUSH. IT WAS REPORTED THAT AFTER THE SOLUTION WAS DELIVERED, THE NURSE DISCONNECTED THE SYRINGE FROM THE CLAVE PORT OF THE TUBING SET. AT THIS TIME, THE CUSTOMER CONTACT REPORTED THAT THE SILICONE SLEEVE OF THE CLAVE PORT REMAINED IN THE DEPRESSED POSITION. IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED 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
    202472 EXT SET 7IN REM CLAVE SITE NDEHP 80FPA FPA HOSPIRA LTD. NA 231694W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 10ML PREFILLED NORMAL SALINE SYRINGE:| MFR BECTON DICKINSON AND COMPANY