BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA

    MDR report key: 14315972 · Received May 7, 2022

    Report

    Report Number
    2243072-2022-00639
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 9, 2022
    Report Date
    June 12, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    NDP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THE REPORTED LOT# 1110343 WAS NOT FOUND FOR THE REPORTED CATALOG# 380074. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 12-JUN-2022. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1110343 . ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY A SAMPLE WAS SUBMITTED TO AID IN OUR INVESTIGATION. LEAKAGE TESTING OF THE RETURNED UNIT FOUND THE DEVICE TO BE FREE OF LEAKAGE AND OPERATING NORMALLY. TORSION TESTING SIMILARLY WAS UNABLE TO IDENTIFY ANY OBSTRUCTIONS TO COMPLETE ACTIVATION. BOTH SETS OF TESTS WERE REPEATED AN ADDITIONAL 4 TIMES ON RETENTION SAMPLES, AND ALL RESULTS WERE REPLICATED. BASED ON THESE TESTS OUR ENGINEERS WERE NOT ABLE TO ASSOCIATE THE ROOT CAUSE WITH THE MANUFACTURING PROCESS. THE ISSUE MAYBE RELATED TO A PARTIAL ACTIVATION DURING USE, BUT THIS CANNOT BE CONFIRMED BY FUNCTIONAL TESTING ALONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA'S FLOW CONTROL VALVE WAS DEFECTIVE AND ALLOWED BLOOD THROUGH DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "AUTOMATIC LOCKING SYSTEM NOT WORKING. BLOOD COMES OUT DESPITE THE OPERATOR CLOSING THE RED LEVER. UNSAFE AND NOT VERY HANDY DEVICE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA'S FLOW CONTROL VALVE WAS DEFECTIVE AND ALLOWED BLOOD THROUGH DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN: "AUTOMATIC LOCKING SYSTEM NOT WORKING. BLOOD COMES OUT DESPITE THE OPERATOR CLOSING THE RED LEVER. UNSAFE AND NOT VERY HANDY DEVICE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204937 BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA ARTERIAL CANNULA NDP BECTON DICKINSON SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown