BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL PE (2 L) / CE W. (JP LABEL)

    MDR report key: 3357963 · Received August 29, 2013

    Report

    Report Number
    9613251-2013-00233
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    July 25, 2013
    Report Date
    July 30, 2013
    Manufacturer
    HOSPIRA, LTD
    Product Code
    GCX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. (B)(4). THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80GCX AND IS EXEMPT FROM 510K. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. THE SUCTION LINER WAS BEING USED TO SUCTION UNSPECIFIED FLUIDS DURING AN UNSPECIFIED PROCEDURE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF FLUID LEAK FROM A PINHOLE OF THE BAG OF THE SUCTION LINER. THE SUCTION LINER WAS REPLACED AND SUCTIONING WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427611 RECEPTAL PE (2 L) / CE W. (JP LABEL) UNK GCX HOSPIRA, LTD NA 25256KZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK