BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 4102637 · Received August 28, 2014

    Report

    Report Number
    9615050-2014-05028
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 18, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET 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 BREAKAGE OF THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER. THE PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER BROKE OFF AND A PIECE REMAINED LODGED INSIDE THE HUB OF THE PATIENT'S IV ACCESS DEVICE. NO SPECIFIC DETAILS WERE PROVIDED. THE PLUMSET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EFFECTS AND NO REPORTED 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
    523723 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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