BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONDEHP LS LF PLUMSET-OLCP D-CHAN

    MDR report key: 4173466 · Received August 7, 2014

    Report

    Report Number
    9615050-2014-04707
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    March 27, 2014
    Report Date
    June 6, 2014
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE TUBING WAS SEPARATED FROM THE MALE ADAPTER OF THE OPTION-LOK. THERE IS TUBING REMAINING WITHIN THE MALE ADAPTOR. THE DEVICE WAS EXAMINED UNDER ULTRA VIOLET LIGHT. AN EXCESS OF SOLVENT SEALER IN THE JOINTS BETWEEN THE TUBING AND THE MALE ADAPTOR WAS FOUND. THIS EXCESS SOLVENT COULD HAVE MELTED THE TUBING CAUSING THE SEPARATION. THE DEVICE CONFIRMS THE CUSTOMER'S REPORTED EVENT. A FACTOR THAT COULD CONTRIBUTE TO THE SEPARATION OF THE TUBING FROM THE MALE ADAPTER IS A WEAK POINT IN THE TUBING CAUSED BY RING OF SOLVENT SEALER THAT IS NORMAL TO BE FOUND AFTER DISPLACEMENT OF SOLVENT SEALER IN THE ASSEMBLY PROCEDURE. THE ASSEMBLY COULD BE ALSO EXPOSED TO A INAPPROPRIATE FORCE THAT JOINTLY WITH THE CONDITION BEFORE REPORTED COULD GENERATE THE SEPARATION EVENT. A PROBABLE CAUSE IS RELATED TO THE REPORTED ISSUE IS A NORMAL ACCUMULATION OF SOLVENT SEALER THAT JOINTLY WITH FORCE APPLY TO THE JOINT BETWEEN THE TUBING AND THE MALE ADAPTOR THAT COULD GENERATE THE SEPARATION. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. 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 SEPARATION. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PATIENT USE, THE NURSE REMOVED THE END CAP OF THE TUBING SET. AT THIS TIME, IT WAS REPORTED THAT THE WHOLE CAP CAME OFF AND SEPARATED AWAY FROM THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. DURING VERIFICATION TESTING AT THE MANUFACTURING FACILITY, IT WAS NOTED THAT THE TUBING WAS SEPARATED FROM THE MALE ADAPTER OF THE TUBING SET. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463162 NONDEHP LS LF PLUMSET-OLCP D-CHAN 80FPA FPA HOSPIRA HOLDINGS DE COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1