BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-PVC RECEPT.LINER 200ML/CE(50/CS)

    MDR report key: 1882896 · Received October 15, 2010

    Report

    Report Number
    9613251-2010-00132
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    July 1, 2010
    Report Date
    September 17, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    GCX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. 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 80GCX AND IS 510K EXEMPT. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED LOW SUCTION. THE DEVICE WAS BEING USED DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT AFTER 5 MINUTES IN USE, THE DEVICE COLLECTED APPROXIMATELY 300ML OF UNSPECIFIED SOLUTION AND IT WAS REPORTED THE "ASPIRATION WAS LOW." THE DEVICE WAS REPLACED AND THE PROCEDURE WAS RESUMED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION INCLUDING THE PROCEDURE BEING PERFORMED AND THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-PVC RECEPT.LINER 200ML/CE(50/CS) UNK GCX HOSPIRA LTD. NA 84166KZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK