BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVERTBL I.V. DUAL CHANNEL HSP

    MDR report key: 3038048 · Received April 1, 2013

    Report

    Report Number
    9615050-2013-00580
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED ON (B)(4) 2013 AND EVALUATED. DURING TESTING, THE SEMI-RIGID ADAPTER SEPARATED FROM THE INLET PORT OF THE FILTER. THE POSSIBLE CAUSE WAS DUE TO THE SOLVENT DRIED PRIOR TO INSERTION OF THE SEMI-RIGID ADAPTER ONTO THE INLET PORT OF THE FILTER. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K982159. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE MANUFACTURING FACILITY, THE SEMI-RIGID ADAPTER SEPARATED FROM THE INLET PORT OF THE FILTER OF THE TUBING SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132414 CONVERTBL I.V. DUAL CHANNEL HSP UNK FRN HOSPIRA COSTA RICA LTD. NA 063155H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA