BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1048 LUMBAR PUNCTURE PED

    MDR report key: 1162299 · Received September 5, 2008

    Report

    Report Number
    1282497-2008-00026
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 29, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MIA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH A LUMBAR PUNCTURE NEEDLE. THE CUSTOMER REPORTS THAT WHILE THE DOCTOR WAS PERFORMING A LUMBAR PUNCTURE ON A PT, THE BLUE PLASTIC PIECE THAT ATTACHES THE NEEDLE SNAPPED IN HALF AND THE NEEDLE WAS LEFT IN THE PT. THE DOCTOR HELD THE PIECES TOGETHER TO COMPLETE THE PROCEDURE, SO HE DID NOT HAVE TO RE-STICK THE PT. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1048 LUMBAR PUNCTURE PED LUMBAR PUNCTURE NEEDLE MIA TYCO HEALTHCARE/KENDALL 1048 7096156

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK