BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 4210820 · Received August 1, 2014

    Report

    Report Number
    9613251-2014-00122
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 10, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CUSTOMER WAS UNABLE TO PROVIDE THE LIST NUMBER OR LOT NUMBER OF THE DEVICE IN USE; HOWEVER, A CUSTOMER PROVIDED PHOTO INDICATED THE DEVICE IN USE WAS AN UNSPECIFIED SECONDARY TUBING SET. 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 BREAKAGE OF THE PIERCING PIN; SUBSEQUENTLY, PARTICULATE WAS NOTED. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF ACYCLOVIR/100ML OF 5% DEXTROSE WHICH WAS COMPOUNDED BY THE USER FACILITY'S PHARMACY. AT AN UNSPECIFIED TIME, THE PIERCING PIN OF THE TUBING SET WAS INSERTED INTO THE ADMINISTRATION PORT OF THE SOLUTION CONTAINER. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT DURING PRIMING PRIOR TO PT USE, THE NURSE NOTED PARTICULATE INSIDE THE COMPOUNDED SOLUTION CONTAINER. THE CUSTOMER CONTACT REPORTED THAT THE SOLUTION CONTAINER AND THE TUBING SET WERE RETURNED TO THE PHARMACY DEPARTMENT. THE CUSTOMER CONTACT INDICATED THAT IN THE PHARMACY, THE SOLUTION CONTAINER WAS CUT, DRAINED, AND THE PARTICULATE WAS TAPED TO A PIECE OF PAPER. THE PARTICULATE WAS DESIRED AS A WHITE, HARD, NON-SOLUBLE, PLASTIC PARTICLE WHICH LOOKS VERY MUCH LIKE THE WHITE PART OF THE SPIKE. NO ADDITIONAL INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452117 UNK UNK FPA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT# 30013JT, MFR HOSPIRA, INC.| SOLUTION CONTAINER 5% DEXTROSE, LIST # 07923,