BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ARTERIAL CANNULA WITH FLOWSWITCH

    MDR report key: 17226163 · Received June 29, 2023

    Report

    Report Number
    8041187-2023-00302
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 8, 2023
    Report Date
    August 1, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 20JUL2023. H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS AND 54 REPRESENTATIVE SAMPLES, 30 FROM BATCH 2231223 AND 24 FROM BATCH 2330967, SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF CATHETER TIP INTEGRITY WAS CONFIRMED UPON INSPECTION OF THE SAMPLE PHOTOS. ANALYSIS OF THE SAMPLE PHOTOS SHOWED THAT THE CATHETER TIP OF THE SAMPLE IN THE PHOTO WAS DAMAGED. HOWEVER, DURING THE SAMPLE EVALUATIONS ALL THE SAMPLES PASSED OUR VISUAL INSPECTION, WITH NO SIGNS OF DAMAGES OR DEFECTS PRESENT. THEREFOR BD COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD¿ ARTERIAL CANNULA WITH FLOWSWITCH THE CATHETER TIP WAS DAMAGED, IT WAS SOFT AND MALLEABLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE END OF THE CANNULA TIP IS SOFT AND MALLEABLE, COLLAPSES WHEN YOU TRY TO FLUSH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD¿ ARTERIAL CANNULA WITH FLOWSWITCH THE CATHETER TIP WAS DAMAGED, IT WAS SOFT AND MALLEABLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE END OF THE CANNULA TIP IS SOFT AND MALLEABLE, COLLAPSES WHEN YOU TRY TO FLUSH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423347 BD¿ ARTERIAL CANNULA WITH FLOWSWITCH INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2330967

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown