BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO 1.8MM X 45MM

    MDR report key: 11676146 · Received April 15, 2021

    Report

    Report Number
    2243072-2021-01173
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 25, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO SAMPLES (INCLUDING PHOTOS) ON LOT #0214124 REGARDING ITEM #393209, VENFLON PRO EU WERE RETURNED FOR THE REPORTED ISSUE OF ¿PORT ACCESSED AT INDUCTION - LEFT OPEN - BLOOD SEEN DRIPPING OUT OF INJECTION PORT SHORTLY AFTER¿, RETENTION SAMPLES WERE USED FOR THE INVESTIGATION.THE LOT NUMBER 0214124 WAS REVIEWED AND WAS FOUND THAT THERE WAS NO QUALITY NOTIFICATION RAISED ON THIS LOT FROM PRODUCTION TO DISPATCH. BD BAWAL HAS RECEIVED NO RETURN SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER. THE INVESTIGATING TEAM HAS THUS USED RETENTION SAMPLES OF LOT NO. 0214124 TO INVESTIGATE THE REPORTED DEFECTS. THE UPPER PORT OF TWO RETENTION SAMPLES WAS INVESTIGATED UNDER THE SMARTSCOPE. THE SMARTSCOPE DID NOT SHOW ANY DEFECT IS THE VALVES OF THE RETENTION SAMPLES. THE UPPER PORT CAP WAS VIEWED UNDER 39X SMARTSCOPE AFTER HIGH PRESSURE OF FLUID WAS PASSED THROUGH THE IV LINE. THIS REVEALED THAT THERE IS A VALVE BURST THAT COULD PROBABLY BE CAUSED DUE TO A STRONG PRESSURE OF FLUID THAT WAS PASSED THROUGH THE VALVE. STRONG PRESSURE OF FLUID COULD BE POSSIBLY HAPPENED DUE TO INFUSION PUMP. BD BAWAL HAS ALSO REACHED OUT TO THE RESEARCH AND DEVELOPMENT AND DESIGN TEAM TO FURTHER INVESTIGATE. BD BAWAL HAS TAKEN FURTHER ACTION AND DONE A SITUATIONAL ANALYSIS ON ALL THE VENFLON PRO LEAKAGE DEFECTS COMPLAINTS TO PREVENT THIS FROM RE-OCCURRING IN THE IVC MANUFACTURED IN BAWAL. WE HAVE ALSO OPENED A CAPA ON THIS COMPLAINT. THE CAPA NUMBER 2807642 AND SA NUMBER IS MDS-21-4111. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VENFLON PRO 1.8MM X 45MM LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "REPORT FROM CUSTOMER IS AS FOLLOWS: PORT ACCESSED AT INDUCTION - LEFT OPEN - BLOOD SEEN DRIPPING OUT OF INJECTION PORT SHORTLY AFTER."

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. 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. 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 A VENFLON PRO 1.8MM X 45MM LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: REPORT FROM CUSTOMER IS AS FOLLOWS: PORT ACCESSED AT INDUCTION - LEFT OPEN - BLOOD SEEN DRIPPING OUT OF INJECTION PORT SHORTLY AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566833 VENFLON PRO 1.8MM X 45MM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 0214124

    Patients

    Seq Age Sex Outcome Treatment
    1