BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIGUIDE CONE NEEDLE

    MDR report key: 92277 · Received May 16, 1997

    Report

    Report Number
    1121753-1997-00010
    Event Type
    Malfunction
    Date Received
    May 16, 1997
    Date of Event
    July 25, 1996
    Report Date
    May 15, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PT TREATMENT, THE TIP OF A FLEXIGUIDE NEEDLE CATHETER SEPARATED FROM THE CATHETER, AND REMAINED INSIDE THE PT WHEN THE CATHETER WAS REMOVED. THE PHYSICIAN CHOSE TO LEAVE THE TINY PIECE OF STERILE PLASTIC INSIDE THE PT, RATHER THAN SUBJECT THE PT TO FURTHER TRAUMA IN A RECOVERY ATTEMPT. THE REPORTER OF THE INCIDENT INDICATED THAT IT WAS NOT UNUSUAL FOR THE TIPS OF THESE NEEDLES TO BREAK OFF, BUT THAT IT USUALLY HAPPENED BEFORE THE NEEDLE ACHIEVED TISSUE PENETRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIGUIDE CONE NEEDLE INTERSTITIAL NEEDLE GCB NUCLETRON CORP. FLEXIBLE PLASTIC CONE,SHARP *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other