BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NT821731C, EDS 3, GEN LL, NO CATHETER

    MDR report key: 17170325 · Received June 21, 2023

    Report

    Report Number
    2023988-2023-00018
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 10, 2023
    Report Date
    August 21, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    JXG
    PMA / PMN Number
    K162437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT #(B)(6). THIRD EVENT. (RELATED TO AE-10273525, AE-10276304). 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 THAT WERE USED TO ASSEMBLE THE DEVICE, SPECIFICALLY THE STOPCOCK PART NUMBER SD205180001 FOUND THERE WERE TWO DIFFERENT STOPCOCK LOT NUMBERS ISSUED TO THE WORK ORDER. LOT NUMBERS 118000747294 (27 PIECES) AND LOT 1180007 46289 (1173 PIECES). LOT NUMBER 118000747294 WAS RECEIVED ON 07-FEB-2022 FOR A QUANTITY OF 4000, THE STOPCOCKS MET THE INCOMING INSPECTION CRITERIA WHICH INCLUDES A SAMPLING FOR LEAK TESTING. THE LOT WAS CONSUMED INTO PRODUCT, WITH THE LAST ISSUE ON 07-JUN-2022. LOT 118000746289 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: (24 MONTHS REVIEW AND PERCENT OF SALES) 0 PREVIOUSLY CONFIRMED "LNTEG-TIGHTEN/HOLD/LOCK" COMPLAINTS WITHIN THE PAST TWO YEARS. 20,152 UNITS SOLD WITHIN PAST TWO YEARS. FAILURE RATE = (B)(4) ROOT CAUSE/FAILURE INVESTIGATION: THE CUSTOMER RETURNED THREE DEVICES FOR EVALUATION, SEE ASSOCIATED COMPLAINTS (B)(6)AND (B)(6). THE EVALUATION CONCLUSION IS AS FOLLOWS: 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 LED TO THE LEAKAGE. STOPCOCK LUER CONNECTORS COMPLY 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 FOR SAMPLES ( CASE #10273525, 10276304, AND 10276304-2). 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. THERE IS NO EVIDENCE OF LEAK FROM THE STOPCOCK (CASE# (B)(6)) AND DO NOT SHOW ANY LEAKAGE DURING THE TESTING. IN THIS CASE, THERE IS A POTENTIAL CHANCE THAT THE USER DID NOT SECURELY CONNECT THE EXTERNAL DEVICE WHEN CONNECTING IT TO THE EDS STOPCOCK LUER CONNECTOR. THE TOTAL NUMBER OF STOPCOCKS FROM BOTH LOTS OF TOTAL(B)(4)PIECES. THESE (B)(4) PIECES WERE CONSUMED IN (B)(4) FINISHED DEVICES. TO DATE A TOTAL OF FIVE REPORTED COMPLAINTS HAVE BEEN REPORTED FOR THE FINISHED GOODS LOT NUMBER CONTAINING THE STOP COCK LOTS LISTED ABOVE, THIS CALCULATES TO A (B)(4) RATE OF OCCURRENCE. IT SHOULD BE NOTED THE FIVE COMPLAINTS WERE REPORTED BY TWO CUSTOMERS AND FROM THE FIVE COMPLAINTS, THREE WERE CONFIRMED. THE CONFIRMED COMPLAINTS WERE DUE TO A TRANSDUCER USED BY THE CUSTOMER ATTACHING THE TRANSDUCER TO THE STOP COCK CAUSING A STRESS CRACK. DEVICE FAILED TO MEET SPECIFICATIONS: NO FAILURE MODE: UNCONFIRMED/ COULD NOT DUPLICATE CUSTOMER COMPLAINT CLOSURE RATIONALE:COMPLAINT COULD NOT BE VERIFIED, MONITOR FOR FUTURE OCCURRENCE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). THIRD EVENT. (RELATED TO (B)(4), (B)(4)). ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 4.33 IN DOC (B)(4) RISK ANALYSIS SPREADSHEET. NO DEATH OR SERIOUS INJURY, CONSIDERED TO BE CUSTOMER INCONVENIENCE. RISK IS CONSIDERED TO BE MODERATE. THERE ARE NO CAPA'S RELATED TO THIS ISSUE AND THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 0 CONFIRMED COMPLAINTS, GIVING A FAILURE RATE OF 0.00%. PER QMS-004442 COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. AFFECTED PART RETURNED FOR EVALUATION. INVESTIGATION RESULTS NOT YET AVAILABLE.

    Description of Event or Problem · 0

    NT821731C, EDS 3, GEN LL, NO CATHETER - NATUS EDS3 WAS LEAKING CEREBROSPINAL FLUID.CUSTOMER PROVIDED A PICTURE STATING THEIR UNIT IS LEAKING CEREBROSPINAL FLUID (CSF). CUSTOMER DOES NOT BELIEVE THE FAILURE IS WITH THE LUER LOCK. NO PATIENT INJURY.

    Description of Event or Problem · 0

    NT821731C, EDS 3, GEN LL, NO CATHETER - NATUS EDS3 WAS LEAKING CEREBROSPINAL FLUID. CUSTOMER PROVIDED A PICTURE STATING THEIR UNIT IS LEAKING CEREBROSPINAL FLUID (CSF). CUSTOMER DOES NOT BELIEVE THE FAILURE IS WITH THE LUER LOCK. UNABLE TO PROVIDE THE ACTUAL LOT NUMBER AS THE BOX WAS DISPOSED OFF. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171956 NT821731C, EDS 3, GEN LL, NO CATHETER NT821731C, EDS 3, GEN LL, NO CATHETER JXG NATUS MEDICAL INCORPORATED 118000952390 NT821731C 118000952390

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown