BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3983145 · Received July 2, 2014

    Report

    Report Number
    9613251-2014-00119
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE LIST NUMBER AND LOT NUMBER OF THE DEVICE THAT WAS IN USE ARE UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED THE DEVICE WAS 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 OPTION-LOK MALE ADAPTER. IT WAS REPORTED THAT A PRIMARY PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT A DELIVERY OF OMEPRAZOLE 20MG/50ML WAS COMPLETE. NO SPECIFIC DETAILS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE OPTION-LOK MALE ADAPTER OF THE SECONDARY TUBINGS ET WAS CONNECTED TO AN UNSPECIFIED CLAVE PORT OF THE PLUMSET FOR THE DELIVERY OF AN UNSPECIFIED ANTIBIOTIC. THE CUSTOMER CONTACT REPORTED THAT TWO HOURS AFTER THE DELIVERY WAS COMPLETE, THE NURSE ATTEMPTED TO CHANGE THE SECONDARY TUBING SET. AT THIS TIME, THE NURSE ATTEMPTED TO DISCONNECT THE OPTION-LOK MALE ADAPTER OF THE SECONDARY TUBING SET FROM THE CLAVE PORT OF THE PLUMSET. THE CUSTOMER CONTACT INDICATED THAT THE NURSE HAD DIFFICULTY DISCONNECTING THE SECONDARY TUBING SET FROM THE CLAVE PORT OF THE PLUMSET. IT WAS REPORTED THAT OPTION-LOK MALE ADAPTER SNAPPED OFF AND A PIECE REMAINED LODGED INSIDE THE CLAVE PORT. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO ADVERSE PATIENT AFFECTS AND NO DELAY IN THERAPY CRITICAL TO THE PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388379 UNK UNK FPA HOSPIRA, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR UNSPECIFIED PRIMARY PLUMSET: LIST/LOT #UNK