BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NT821731C, EDS 3, GEN LL, NO CATHETER

    MDR report key: 16944208 · Received May 17, 2023

    Report

    Report Number
    2023988-2023-00012
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 25, 2023
    Report Date
    August 18, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    JXG
    PMA / PMN Number
    K162437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UPL REPORT 001 REF TO NATUS COMPLAINT #(B)(4). DHR REVIEW: THE DEVICE HISTORY RECORD WAS REVIEWED, THE RAW MATERIALS USED IN THE MANUFACTURING MET SPECIFICATIONS AND THERE WERE NO ANOMALIES OBSERVED DURING THE MANUFACTURING, PACKAGING, OR INSPECTION OF THE DEVICE IN PROCESS. A REVIEW OF THE COMPONENTS USED TO ASSEMBLE THE DEVICE, SPECIFICALLY THE STOPCOCK PART NUMBER SD205180001 FOUND ONE LOT (118000746289) ISSUED TO THE WORK ORDER. LOT NUMBER 1180007 46289 WAS RECEIVED ON 05-FEB-2022 FOR A QUANTITY OF 6000, THE STOPCOCKS MET THE INCOMING INSPECTION CRITERIA WHICH INCLUDES A SAMPLING FOR LEAK TESTING. THE LOT WAS CONSUMED INTO PRODUCT, WITH THE LAST ISSUE IN MARCH 2023. CAPA REVIEW: A REVIEW OF CAPA'S INITIATED WITHIN THE PAST 12 MONTHS, WERE REVIEWED TO DETERMINE IF ANY CAPAS WERE GENERATED SPECIFICALLY RELATED TO THE CUSTOMER'S COMPLAINT. THE REVIEW FOUND ZERO (0) CAPAS WHERE THE SCOPE IS RELATED TO THIS COMPLAINT INCIDENT. COMPLAINT HISTORY REVIEW/TREND ANALYSIS: 1 PREVIOUSLY CONFIRMED "LNTEG-TIGHTEN/HOLD/LOCK" COMPLAINTS WITHIN THE PAST TWO YEARS. 14,082 NT821731 C UNITS SOLD WITHIN PAST TWO YEARS. FAILURE RATE = (B)(4) ROOT CAUSE/FAILURE INVESTIGATION: THE COMPLAINT WAS CONFIRMED, VISUAL INSPECTION FOUND A STRESS CRACK ON THE STOPCOCK AND THE STOPCOCK WOULD LEAK WHEN IN THE MONITORING POSITION. THE LEAK WAS DUE TO THE CRACK FOUND ON THE STOPCOCK. THE CRACK IS MOST LIKELY DUE TO THE EXTERNAL (NON-NATUS PRODUCT) TRANSDUCER ATTACHED TO THE STOPCOCK. THE LUER CONNECTOR WAS ALSO DAMAGED LOCATED UNDER THE SURETTE TUBE, BASED ON THE PHYSICAL CONDITION OF THE LUER IT APPEARS THERE WAS A TOOL USED TO TIGHTEN OR UNTIGHTEN THE LUER CAUSING THE LUER TO CRACK. ENGINEERING EVALUATION CONCLUSION: THE CRACKS/FRACTURES ON THE STOPCOCK LUER CONNECTORS ARE DUE TO APPLYING MORE STRESS WHEN CONNECTING/DISCONNECTING THE EXTERNAL CONNECTORS, THE USER MISUSED THE DEVICE WHILE CONNECTING AN EXTERNAL CONNECTOR TO THE STOPCOCK WHICH LEAD TO THE LEAKAGE. STOPCOCK LUER CONNECTORS ARE IN COMPLIANCE WITH THE ISO 80369-7 LUER STANDARDS. CRACKS CAN BE EASILY IDENTIFIED AND DETECTED DURING THE PRODUCTION PROCESS. THERE IS STRESS CRACKING ON THE STOPCOCK LUER LOCK CONNECTOR AND IN THIS CASE, THERE IS A POTENTIAL CHANCE THAT THE USER DAMAGED THE STOPCOCK LUER CONNECTOR WHILE CONNECTING THE EXTERNAL DEVICE WHICH LEADS TO THIS LEAKAGE. DEVICE FAILED TO MEET SPECIFICATIONS: YES FAILURE MODE: CONFIRMED/LEAK DUE TO DAMAGED STOPCOCK (DAMAGE DUE TO EXTERNAL TRANSDUCER USED BY THE CUSTOMER). CLOSURE RATIONALE: COMPLAINT VERIFIED, RESOLVED ON-SITE AND NO FURTHER ACTION NECESSARY. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). CUSTOMER ASKED TO CONFIRM IF THEY HAVE ANY PRODUCT AVAILABLE FOR TESTING. CUSTOMER CONFIRMS THEY HAVE ONE DRAIN AVAILABLE. CUSTOMER CONFIRMED THE PART WILL BE RETURNED. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 4.33 IN DOC-035405 RISK ANALYSIS SPREADSHEET. RISK IS CONSIDERED TO BE MODERATE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    NT821731C. , EDS 3, GEN LL, NO CATHETER - CSF LEAKS NEAR THE TRANSDUCER CONNECTION/DRAIN STOPCOCK DURING USE OF THE EVD. DURING A BAG CHANGE ON (B)(6) 2023, THE PIECE WHERE THE DRAINAGE BAG ATTACHES TO THE DRAIN BROKE INTO PIECES. CSF LEAKAGE WAS OBSERVED. NEW EVD WAS PLACED AT BEDSIDE VIA NEUROSURGERY. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED, NO PATIENT INJURY.

    Description of Event or Problem · 0

    NT821731C, EDS 3, GEN LL, NO CATHETER - CSF LEAKS NEAR THE TRANSDUCER CONNECTION/DRAIN STOPCOCK DURING USE OF THE EVD. DURING A BAG CHANGE ON (B)(6) 2023, THE PIECE WHERE THE DRAINAGE BAG ATTACHES TO THE DRAIN BROKE INTO PIECES. CSF LEAKAGE WAS OBSERVED. NEW EVD WAS PLACED AT BEDSIDE VIA NEUROSURGERY. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED, NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423872 NT821731C, EDS 3, GEN LL, NO CATHETER NT821731C, EDS 3, GEN LL, NO CATHETER JXG NATUS MEDICAL INCORPORATED NT821731C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown