BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON I 22GA 0.8 MM X 25MM

    MDR report key: 9534210 · Received December 31, 2019

    Report

    Report Number
    2243072-2019-02914
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 10, 2019
    Report Date
    January 8, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿CATHETER IS DAMAGING WHILE INSERTING (PEEL OFF) WASTAGE OF MANY CANNULA¿ WITH LOT NUMBER 9145936 AND 9171588 REGARDING ITEM # 391591 THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. WE INVESTIGATED BATCH NUMBER 9145936 AND 9171588 FOR MATERIAL NUMBER 391591 AND THE DHR SHOWED NO REPORTED QN DURING ITS PRODUCTION TO RELEASE OF THE BATCH. NO SAMPLES OR PHOTO(S) WERE RECEIVED FOR INVESTIGATION BY BD TO CONFIRM THE INDICATED FAILURE. THE RETENTION SAMPLES WERE USED FOR INVESTIGATION. THE PENETRATION TEST FOUND TO BE WITHIN THE SPECIFICATION LIMIT AND NO PEEL BACK WAS OBSERVED. THE MANUFACTURING TEAM INSPECTED VARIOUS PRODUCT CHARACTERISTICS SUCH AS BEVEL ANGLE, PTFE TUBE THICKNESS, CANNULA OUTER DIAMETER FROM THE RETENTION SAMPLES OF THE REPORTED LOTS. THE TEST RESULTS SHOWED THAT ALL THESE CHARACTERISTICS CONFORMED TO THE PRODUCT DRAWING SPECIFICATIONS. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON I 22GA 0.8 MM X 25MM CATHETER IS DAMAGED. THIS OCCURRED ON 20 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER IS DAMAGING WHILE INSERTING (PEEL OFF) WASTAGE OF MANY CANNULA.

    Additional Manufacturer Narrative · 1

    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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9145936. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-05-25. MEDICAL DEVICE LOT #: 9171588. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-06-20. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENFLON I 22GA 0.8 MM X 25MM CATHETER IS DAMAGED. THIS OCCURRED ON 20 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER IS DAMAGING WHILE INSERTING (PEEL OFF) WASTAGE OF MANY CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331638 VENFLON I 22GA 0.8 MM X 25MM CATHETER FOZ BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other