BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 4152547 · Received October 6, 2014

    Report

    Report Number
    9615050-2014-05488
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 16, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 DISTAL TIP OF THE OPTION-LOK MALE ADAPTER. THE PLUMSET WAS CONNECTED TO THE PATIENT'S PERIPHERAL IV ACCESS DEVICE AND WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE ATTEMPTED TO DISCONNECT THE OPTION-LOK MALE ADAPTER OF THE PLUMSET FROM THE PATIENT'S IV ACCESS DEVICE. AT THIS TIME, IT WAS REPORTED THAT THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER BROKE OFF. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT INDICATED THAT THE THERAPY HAD BEEN COMPLETED; THEREFORE, THE PLUMSET WAS NOT REPLACED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EFFECTS AND NO DELAY IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622133 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED IV ACCESS DEVICE, MFR UNK