BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NT821707, DRAINAGE KIT, LUMBAR

    MDR report key: 20509413 · Received October 22, 2024

    Report

    Report Number
    2023988-2024-00072
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    July 1, 2024
    Report Date
    November 27, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    JXG
    UDI-DI
    00382830050531
    PMA / PMN Number
    K964923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). THE LOT NUMBER OF THE AFFECTED PART WAS NOT CONFIRMED. DEVICE IDENTIFIER (UDI NUMBER) : N/A RISK REVIEW: (B)(4) REV 05 NATUS EXTERNAL DRAINAGE LUMBAR CATHETERS - RISK ANALYSIS SPREADSHEET HAZARD 1.5 - CATHETER TUBING IS CUT BY SHARP INNER EDGE OF NEEDLE WHILE ACCESSING INTO LUMBAR SPINE AND A CATHETER PIECE IS LEFT IN THE PATIENT BODY. EFFECT (HARM): SURGICAL INTERVENTION RESIDUAL RISK: MEDIUM. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT#: (B)(4). CAPA: 005401 IS NOTED TO BE RELATED, CAPA WAS CLOSED IN 2022. COMPLAINT HISTORY REVIEW/TREND ANALYSIS: (24 MONTHS REVIEW AND PERCENT OF SALES) 1 PREVIOUSLY CONFIRMED "INTEG-BROKE/DISENGAGE" COMPLAINTS WITHIN THE PAST TWO YEARS. (B)(4) NT821707 UNITS SOLD WITHIN PAST TWO YEARS. FAILURE RATE: (B)(4). ROOT CAUSE/FAILURE INVESTIGATION: THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION OR PROVIDE ANY FURTHER INFORMATION REGARDING THE ALLEGED COMPLAINT. FAILURE MODE: NO DEVICE RETURNED - UNABLE TO DETERMINE.

    Description of Event or Problem · 0

    PART 821707 CODMAN* LUMBAR CATHETER KIT REOPERATIVE PLACEMENT OF LUMBAR DRAIN - ENCOUNTERED RESISTANCE DURING INITIAL PLACEMENT, LUMBAR DRAIN REMOVED AND NOTED TO HAVE THE END OF THE TUBING SHEARED OFF, <1MM, WIRE REMAINED INTACT. SECOND LUMBAR DRAIN PLACED SUCCESSFULLY. NO HARM TO PATIENT.

    Description of Event or Problem · 0

    NT821707, DRAINAGE KIT, LUMBAR REOPERATIVE PLACEMENT OF LUMBAR DRAIN - ENCOUNTERED RESISTANCE DURING INITIAL PLACEMENT, LUMBAR DRAIN REMOVED AND NOTED TO HAVE THE END OF THE TUBING SHEARED OFF, <1MM, WIRE REMAINED INTACT. SECOND LUMBAR DRAIN PLACED SUCCESSFULLY. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790565 NT821707, DRAINAGE KIT, LUMBAR NT821707, DRAINAGE KIT, LUMBAR JXG NATUS MEDICAL INCORPORATED NT821707 00382830050531

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female