BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON I 20GA 1.0 MM X 32MM

    MDR report key: 11372071 · Received February 24, 2021

    Report

    Report Number
    2243072-2021-00589
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 28, 2021
    Report Date
    March 3, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/2/2021. H.6. INVESTIGATION: THE SAMPLES WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED (5) VENFLON 1 20GA FROM LOT # 0210959 PRODUCT # 391592 WITH THE REPORTED ISSUE OF ¿CATHETER TIP DAMAGED¿. THE DHR WAS REVIEWED AND NO NCP OR QN WAS RAISED ON THIS LOT DURING MANUFACTURING AND PRODUCTION OF THE LOT NUMBER 0210959 UNTIL LOT RELEASE. CUSTOMER RETURNED SAMPLES AND PHOTOGRAPH ARE AVAILABLE FOR INVESTIGATION. THE TEAM HAS INVESTIGATED THE SAMPLES AND FOUND THE DEFECT TO BE PRESENT ON ONE OF THE SAMPLES. THE DEFECT IS CONFIRMED. THE CANNULA TIP WAS FOUND TO BE BENT AND UNEVENLY CUT ON ONE OF THE SAMPLES IN THE CUSTOMER RETURN SAMPLES. THE INVESTIGATING TEAM HAS ANALYZED THE COMPLETE PROCESS OF THE MANUFACTURING ON THE MACHINE AND CONCLUDED THAT THE PROBABLE ROOT CAUSE OF THE TIP DAMAGE MAY HAVE OCCURRED DURING THE PROCESS OF RELOADING ON VA 35. RELOADING OF THE COMPONENTS THAT FALL OFF THE CONVEYOR ARE RELOADED MANUALLY. THIS DEFECT COULD BE A ONE OF CASE CAUSED BY HUMAN ERROR DUE TO MANUAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON I 20GA 1.0 MM X 32MM CATHETER TIP WAS DAMAGED. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER TIP DAMAGED FOUND IN VENFLON I 20G.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENFLON I 20GA 1.0 MM X 32MM CATHETER TIP WAS DAMAGED. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER TIP DAMAGED FOUND IN VENFLON I 20G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270056 VENFLON I 20GA 1.0 MM X 32MM CATHETER FOZ BECTON DICKINSON 0210959

    Patients

    Seq Age Sex Outcome Treatment
    1