BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUET EDMS WITH SMARTSITE NEEDLELESS INJECTION SITES

    MDR report key: 3761335 · Received April 21, 2014

    Report

    Report Number
    2021898-2014-00125
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 23, 2014
    Report Date
    March 24, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K983799
    Removal / Correction Number
    Z-1921-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED UNIT WAS PATENT. THE DISTAL PATIENT LINE TUBING WAS OBSERVED TO BE DISCONNECTED FROM THE TUBING JOINT AT THE PATIENT LINE STOPCOCK. ADHESIVE WAS OBSERVED INSIDE AND OUTSIDE OF THE TUBING JOINT. THE DISCONNECTED TUBING LED TO THE DEVICE NOT MEETING REQUIREMENTS FOR THE LEAKAGE TEST. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. (B)(4)

    Additional Manufacturer Narrative · 1

    THE RETURNED UNIT WAS PATENT. THE DISTAL PATIENT LINE TUBING WAS OBSERVED TO BE DISCONNECTED FROM THE TUBING JOINT AT THE PATIENT LINE STOPCOCK. ADHESIVE WAS OBSERVED INSIDE AND OUTSIDE OF THE TUBING JOINT. THE DISCONNECTED TUBING LED TO THE DEVICE NOT MEETING REQUIREMENTS FOR THE LEAKAGE TEST. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A DUET'S TUBING BECAME DISCONNECTED AT THE PATIENT LINE STOPCOCK AND WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240335 DUET EDMS WITH SMARTSITE NEEDLELESS INJECTION SITES SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1