BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON CATHETER

    MDR report key: 18016454 · Received October 26, 2023

    Report

    Report Number
    2243072-2023-01946
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 9, 2023
    Report Date
    October 27, 2023
    Manufacturer
    BD MEDICAL, MEDICATION DELIVERY SOLUTIONS
    Product Code
    FOZ
    UDI-DI
    00382903915910
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP MDR SUPPLEMENTAL FOR DEVICE EVALUATION NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿CATHETER KINK / BENT¿ WITH LOT NUMBER 3192030 REGARDING ITEM # 391591, SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE DEVICE HISTORY REVIEW (DHR) OF MATERIAL NUMBER 391591 WITH LOT NUMBER 3192030 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT NUMBER FROM ITS PRODUCTION DATE TO ITS DISPATCH ON DATE. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON 01 RETENTION SAMPLE WHERE THE INVESTIGATING TEAM HAS VISUALLY INSPECTED THE SAMPLES FOR CATHETER KINK / BENT AND NO SUCH TYPE OF DEFECT WAS FOUND IN 01 RETENTION SAMPLE.

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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

    NO ADDITIONAL INFORMATION RECEIVED. INDWELLING DAYS OF CANNULA REDUCED BECAUSE OF CANNULA KINKING. WHILE REMOVING THE CANNULA NURSES OBSERVED TIP OF THE CANNULA KINKED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BD VENFLON CATHETER WAS KINKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: INDWELLING DAYS OF CANNULA REDUCED BECAUSE OF CANNULA KINKING. WHILE REMOVING THE CANNULA NURSES OBSERVED TIP OF THE CANNULA KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023357 BD VENFLON CATHETER INTRAVASCULAR CATHETER FOZ BD MEDICAL, MEDICATION DELIVERY SOLUTIONS 3192030 00382903915910

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown