BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT LUMBAR PUNCTURE TRAY 20X3 1/2

    MDR report key: 334639 · Received May 24, 2001

    Report

    Report Number
    1423507-2001-00162
    Event Type
    Malfunction
    Date Received
    May 24, 2001
    Date of Event
    April 20, 2001
    Report Date
    May 24, 2001
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    IQE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SPOKE WITH ASST. NURSE MGR ON 4/30/01, WHO STATED ON THE DAY OF THE EVENT, A PT HAD A LUMBAR PUNCTURE PERFORMED. THE STOPCOCK LEAKED AND THEY WERE UNABLE TO OBTAIN A PRESSURE READING. THEY OPENED ANOTHER KIT AND HAD THE SAME EXPERIENCE. THEY SCHEDULED A FOLLOW UP LUMBAR PUNCTURE FOR THE FOLLOWING TUESDAY. AT THAT TIME, THE CHILD HAD THE THIRD LUMBAR PUNCTURE, AND THEY WERE ABLE TO OBTAIN A PRESSURE READING AND NOTED THAT THE EXTENSION TUBING WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24608 ADULT LUMBAR PUNCTURE TRAY 20X3 1/2 PROCEDURE TRAY IQE ALLEGIANCE HEALTHCARE CORP. 4301C L0P049

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other