BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER

    MDR report key: 4123681 · Received September 26, 2014

    Report

    Report Number
    2021898-2014-00388
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    PMA / PMN Number
    K862303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS PATENT. IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO CRACKS ON THE INJECTION PORT ARM OF THE STOPCOCK. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE (IFU) THAT ACCOMPANIES THE DEVICE CAUTION THAT ¿IN ORDER TO AVOID POSSIBLE CRACKING OF THE LUER CONNECTORS AFTER CLEANING WITH ALCOHOL, OR A DISINFECTANT CONTAINING ALCOHOL ALLOW TO AIR DRY COMPLETELY PRIOR TO CONNECTING THE SYSTEM¿. ALSO, THE IFU CAUTIONS THAT ¿ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR¿. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER USING THE PRODUCT, THE PHYSICIAN FOUND THAT THE THREE-WAY CONNECTOR WAS LEAKING. ACCORDING TO THE REPORT, THE PHYSICIAN HAD TO USE ANOTHER PRODUCT TO COMPLETE THE SURGERY. REPORTEDLY, THE PATIENT¿S CURRENT CONDITION IS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599951 EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY 207893085

    Patients

    Seq Age Sex Outcome Treatment
    1