BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NT821707, DRAINAGE KIT, LUMBAR

    MDR report key: 20509422 · Received October 22, 2024

    Report

    Report Number
    2023988-2024-00073
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    August 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

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT#: (B)(4). DEVICE STERILE DATE: ON (B)(6) 2024. COMPLAINT HISTORY REVIEW/TREND ANALYSIS: (24 MONTHS REVIEW AND PERCENT OF SALES) 2 PREVIOUSLY CONFIRMED "INTEG-BROKE IN USE" COMPLAINTS WITHIN THE PAST TWO YEARS. (B)(4) NT821707 UNITS SOLD WITHIN PAST TWO YEARS. FAILURE RATE: (B)(4). CAPA: 005401 IS NOTED TO BE RELATED, CAPA WAS CLOSED IN 2022. DEVICE HISTORY RECORD REVIEW: UNIT HAS PASSED ALL THE REQUIRED TESTS. NO MANUFACTURING DEFECTS OR NON-CONFORMANCE'S OBSERVED. 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.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT (B)(4). 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.

    Description of Event or Problem · 0

    NT821707, DRAINAGE KIT, LUMBAR WHILE PERFORMING A LUMBAR DRAIN AT THE BEDSIDE - A PIECE OF THE SOFT TUBING WAS SHEARED AND LEFT IN THE THECAL SAC. THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; DEVICE WAS HARD TO USE.

    Description of Event or Problem · 0

    PART 821707 CODMAN* LUMBAR CATHETER KIT - WHILE PERFORMING A LUMBAR DRAIN AT THE BEDSIDE - A PIECE OF THE SOFT TUBING WAS SHEARED AND LEFT IN THE THECAL SAC. THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; DEVICE WAS HARD TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790573 NT821707, DRAINAGE KIT, LUMBAR NT821707, DRAINAGE KIT, LUMBAR JXG NATUS MEDICAL INCORPORATED NT821707 118001039913 00382830050531

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female