BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA

    MDR report key: 15700735 · Received October 31, 2022

    Report

    Report Number
    2243072-2022-01856
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    September 28, 2022
    Report Date
    December 11, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903800742
    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

    H.6. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1120043. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    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# 1120043 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA SHUT-OFF VALVE MALFUNCTIONED AND LEAKED BLOOD AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN: "MALFUNCTIONING OF THE SHUT-OFF VALVE WITH BLOOD LOSS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA SHUT-OFF VALVE MALFUNCTIONED AND LEAKED BLOOD AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN: "MALFUNCTIONING OF THE SHUT-OFF VALVE WITH BLOOD LOSS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2950803 BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA ARTERIAL CANNULA FOZ BECTON DICKINSON SEE H10 00382903800742

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown