BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY SET CAIR CLAMP NON-DEHP

    MDR report key: 3964074 · Received May 5, 2014

    Report

    Report Number
    9615050-2014-03215
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 8, 2014
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K101677. 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 UNRESTRICTED FLOW. THE TUBING SET WAS TO BE USED TO DELIVER 1L NORMAL SALINE, AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PATIENT USE, THE PIERCING PIN OF THE TUBING SET WAS INSERTED INTO AN UNSPECIFIED ADMINISTRATION PORT OF THE SOLUTION CONTAINER. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE SOLUTION CONTAINER AND TUBING SET WERE HUNG ON AN IV POLE. THE CUSTOMER CONTACT REPORTED THAT THE CAIR CLAMP OF THE TUBING SET WAS IN THE CLOSED POSITION, FULLY CLAMPED CORRECTLY AND UNABLE TO MOVE ON THE LINE. AT THIS TIME, IT WAS REPORTED THAT SOLUTION STARTED SLOWLY DRIPPING DOWN THE LINE. THE CUSTOMER CONTACT INDICATED THAT A SCISSOR CLAMP WAS APPLIED TO STOP THE DRIPPING OF SOLUTION. NO SPECIFIC DETAILS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE THERAPY WAS INITIATED WITH THE SAME TUBING SET. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268336 SECONDARY SET CAIR CLAMP NON-DEHP UNK FPA HOSPIRA COSTA RICA LTD. NA 330185H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA