BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT LUMBAR PUNCTURE TRAY 20X3 1/2

    MDR report key: 558358 · Received May 7, 2004

    Report

    Report Number
    1423507-2004-00044
    Event Type
    Malfunction
    Date Received
    May 7, 2004
    Report Date
    May 7, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    IQE
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PT ON TABLE DOING PROCEDURE, THE SPINAL NEEDLE/HUB (DEFECTIVE), MATERIAL SPRAYED ALL OVER THE HUB. DR WAS HIGHLY UPSET. PT NOW HAS TO COME BACK TO DO PROCEDURE AGAIN. NO SAMPLE AVAILABLE DUE TO HIGH RADIATION LEVELS, IT WAS PUT IN DISPOSABLE UNIT. ADDITIONALLY, CONTACT STATED THEY WERE DOING A LP USING RADIOACTIVE DYE AND WHEN THE PHYSICIAN PUSHED ON THE SYRINGE, THE DYE SPRAYED ALL OVER. THEY DECIDED TO PROCEED WITH THE X-RAYS, AND THE DYE DID NOT ENTER THE PT'S SYSTEM AS DESIRED. THE DECISION TO ABORT THE PROCEDURE WAS MADE AT THAT TIME AND THE PT HAS BEEN RESCHEDULED. THE MEDICAL TEAM PERFORMING THE PROCEDURE DID NOT REQUIRE ANY ADD'L MEDICAL INTERVENTION AS A RESULT OF THE INCIDENT. BASED ON THE FACT THAT THE PT WILL REQUIRE A SECOND PROCEDURE THIS COMPLAINT WILL BE FILED WITH THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT LUMBAR PUNCTURE TRAY 20X3 1/2 PROCEDURE TRAY IQE CARDINAL HEALTH 4301C L4A123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other