BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENCAN

    MDR report key: 372583 · Received January 18, 2002

    Report

    Report Number
    2523676-2002-00063
    Event Type
    Other
    Date Received
    January 18, 2002
    Date of Event
    December 19, 2001
    Report Date
    January 17, 2002
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SPINAL NEEDLE SEPARATED FROM HUB DURING WITHDRAWAL OF NEEDLE AND REMAINED IN PATIENT'S BACK. THE NEEDLE WAS RETRIEVED WITHOUT INCIDENT. PATIENT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENCAN SPINAL TRAY CAZ B. BRAUN MEDICAL, INC. P25BK 60255047

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention