BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL NEEDLE (PENCIL POINT)

    MDR report key: 2915243 · Received January 9, 2013

    Report

    Report Number
    9681709-2013-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    February 5, 2007
    Manufacturer
    SMITHS MEDICAL
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A RETROSPECTIVE REPORT DUE TO WARNING LETTER RELATED TO OBSERVATION OF FDA INSPECTION CONDUCTED ON (B)(4), 2012. WE DO NOT HAVE DETAILED INFORMATION ON PT INFORMATION, ADVERSE EVENTS, MEDICAL DEVICE, AND SO ON, BECAUSE WE ARE AN (B)(4) SUPPLIER.

    Description of Event or Problem · 1

    THERE WAS A PROBLEM DURING INSERTION OF THE NEEDLE (PENCIL POINT 26G X 90MM). WHEN THE NEEDLE WAS WITHDRAWN, IT WAS BENT. MFR LOT #: 05H017-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12379 SPINAL NEEDLE (PENCIL POINT) BSP SMITHS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER (20G X 38MM)