BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERMETIC LUMBAR CATHETER, OPEN TIP

    MDR report key: 8802568 · Received July 18, 2019

    Report

    Report Number
    2648988-2019-00078
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 19, 2019
    Report Date
    June 28, 2019
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K970658
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI NUMBER: (B)(4). ONE UNIT WAS RECEIVED FOR EVALUATION. THE CATHETER WAS NOT IN ITS ORIGINAL PACKAGE; THEREFORE, THE REPORTED LOT NUMBER COULD NOT BE VERIFIED. THE UNIT WAS VISUALLY INSPECTED, AND A TEAR WAS OBSERVED ON THE CATHETER. A PIECE OF BLUE THREAD WAS TIED AROUND THE CATHETER CLOSE TO THE TEAR. THE COMPLAINT ¿A TEAR IN CATHETER WAS FOUND¿ IS CONFIRMED. NO ANOMALY WAS FOUND IN THE DOCUMENTATION REVIEW THAT COULD BE RELATED TO THE REPORTED CONDITION. THERE ARE CONTROLS TO ENSURE THAT NO BROKEN CATHETER TUBES ARE RELEASED TO THE MARKET. THE REPORTED CONDITION WAS OBSERVED ON THE SECOND DAY OF USE, DURING A DRESSING CHANGE. THE TYPE OF TEAR OBSERVED IN THE RETURNED UNIT WAS OBVIOUS AND IT WOULD HAVE BEEN NOTICED DURING INITIAL DEVICE SETUP/INSERTION PROCESS; THEREFORE, IT IS NOT AN OUT OF THE BOX (OOB) CONDITION. THE MOST PROBABLE ROOT CAUSE FOR THIS TEAR IS THAT THE DEVICE WAS INADVERTENTLY PULLED/TORN DURING USE.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE NL8508330 HERMETIC LUMBAR CATHETER HAD A TEAR ON THE CATHETER. THIS WAS DISCOVERED DURING THE DRESSING CHANGE ON (B)(6) 2019. NO INJURY TO THE PATIENT WAS REPORTED. HOWEVER, THE CATHETER WAS CHANGED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597903 HERMETIC LUMBAR CATHETER, OPEN TIP N/A JXG INTEGRA NEUROSCIENCES PR 3247376

    Patients

    Seq Age Sex Outcome Treatment
    1