BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA

    MDR report key: 15310804 · Received August 29, 2022

    Report

    Report Number
    2243072-2022-01413
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 2, 2022
    Report Date
    November 27, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    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 DELTA MED. 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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 21-SEP-2022. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1110343. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. 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, 35 SAMPLES ALONG WITH A VIDEO DISPLAY A LEAKING UNIT WERE SUBMITTED TO AID IN OUR INVESTIGATION. BASED ON THE VIDEO EVIDENCE, OUR ENGINEERS WERE ABLE TO CONFIRM THE OCCURRENCE OF LEAKAGE BUT WERE UNABLE TO MAKE OUT ANY CHARACTERISTICS THAT WOULD INDICATE A SPECIFIC ROOT CAUSE. THE SUBMITTED SAMPLES WERE ALSO SUBJECTED TO FUNCTIONAL TESTING FOR PENETRATION FORCE, CATHETER KINKING , AND LEAK DETECTION, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS AND WERE FREE OF ANY OBSERVABLE NON CONFORMANCES. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OR REPLICATE THE REPORTED NON-CONFORMANCE OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA LEAKED BLOOD FROM BELOW THE VALVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN: BLOOD LOSS BELOW THE RED ON/OFF VALVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA LEAKED BLOOD FROM BELOW THE VALVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN: BLOOD LOSS BELOW THE RED ON/OFF VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594456 BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA ARTERIAL CANNULA FOZ BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown