BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET 7IN REM CLAVE SITE NDEHP

    MDR report key: 2913396 · Received January 9, 2013

    Report

    Report Number
    9613251-2013-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DISCONNECTION. ON AN UNSPECIFIED DATE, THE TUBING SET WAS TO USED TO DELIVER UNSPECIFIED MEDICATIONS. IT WAS REPORTED THE PROXIMAL REMOVABLE CLAVE PORT OF THE TUBING SET WAS NOT TIGHTENED ON THE TUBING SET PRIOR TO CLINICAL USE. THE CUSTOMER CONTACT REPORTED THAT WHILE THE NURSE WAS CONNECTING THE SECURE LOCK MALE ADAPTER TO THE PT'S IV ACCESS SITE, THE REMOVABLE CLAVE PORT DISCONNECTED FROM THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY RESUMED. THERE WERE NO REPORTED ADVERSE EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13395 EXT SET 7IN REM CLAVE SITE NDEHP 80FPK FPK HOSPIRA LTD. NA 101834W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK