BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO 1.1MM X 32MM

    MDR report key: 11490298 · Received March 15, 2021

    Report

    Report Number
    2243072-2021-00792
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 9, 2021
    Report Date
    March 17, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0148748, D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, H.4. DEVICE MANUFACTURE DATE: 2020-05-27. D.4. MEDICAL DEVICE LOT #: 0112800, D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, H.4. DEVICE MANUFACTURE DATE: 2020-05-27. H.6. INVESTIGATION: SINCE NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿LEAKAGE¿, WITH REPORTED LOT # 0.0148748 AND 0112800 REGARDING ITEM # 393204, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. THE DHR WAS REVIEWED AND QN WAS RAISED ON THIS LOT DURING MANUFACTURING AND PRODUCTION OF LOT NUMBER 0.0148748 AND 0112800 UNTIL LOT RELEASE. BD BAWAL HAS RECEIVED NO CUSTOMER RETURN SAMPLE OF THE DEFECTIVE PRODUCT ON WHICH THE COMPLAINT HAS BEEN REGISTERED. WE HAVE SIMULATED THE DEFECT ON THE RETENTION SAMPLES OF LOT NUMBER 0.0148748 AND 0112800 AS DESCRIBED BY THE CUSTOMER TO DETERMINE THE DEFECT AND UNDERSTAND THE COMPLAINT FOR FURTHER INVESTIGATION. AFTER INVESTIGATING THE COMPLAINT BY SIMULATING THE DEFECT ON THE RETENTION SAMPLES. OUR INVESTIGATING TEAM DID NOT FIND LEAKAGE FROM THE TOP PORT PINK CHIMNEY OF THE VENFLON PRO 22G IN THE RETENTION SAMPLES OF LOT NUMBER 0.0148748 OR 0112800. THE REPORTED DEFECT IS NOT CONFIRMED. THE PROBABLE ROOT CAUSES OF LEAKAGE FROM THE CHIMNEY PORT COULD BE 1. SHIFTING OF THE VALVE OR 2. COULD BE MISAPPROPRIATE DOSE OF IPA(ISO PROPYL ALCOHOL) OR 3. IT COULD ALSO BE DUE TO BURSTING OF THE VALVE DUE TO HEAVY FLUID PRESSURE WHILE CHECKING VENFLON WITH 10 ML NACL H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENFLON PRO 1.1MM X 32MM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF BLOOD AND CONTRAST THROUGH THE CHIMNEY ON. VENFLON BROUGHT BY ANESTHESIA STAFF. BY CONTRAST ADMINISTRATION RAN THE CONTRAST OUTSIDE VENFLON. THERE WAS CHECKED THAT THE CONTRAST HOSE WAS PROPERLY FITTED VENFLONET, WHICH WAS THE CASE. SUBSEQUENTLY THERE WAS LEAKAGE OF BLOOD THROUGH THE PINK CAP (CHIMNEY) ON THE VENFLONET. VENFLON WAS CHECKED WITH 10ML NACL WITHOUT PROBLEMS AND THERE WAS REFLUX MOUNTING OF CONTRAST HOSE. (PVK USED IS SAVED AND CAN BE SENT TO YOU).

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE VENFLON PRO 1.1MM X 32MM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF BLOOD AND CONTRAST THROUGH THE CHIMNEY ON. VENFLON BROUGHT BY ANESTHESIA STAFF. BY CONTRAST ADMINISTRATION RAN THE CONTRAST OUTSIDE VENFLON. THERE WAS CHECKED THAT THE CONTRAST HOSE WAS PROPERLY FITTED VENFLONET, WHICH WAS THE CASE. SUBSEQUENTLY THERE WAS LEAKAGE OF BLOOD THROUGH THE PINK CAP (CHIMNEY) ON THE VENFLONET. VENFLON WAS CHECKED WITH 10ML NACL WITHOUT PROBLEMS AND THERE WAS REFLUX MOUNTING OF CONTRAST HOSE. (PVK USED IS SAVED AND CAN BE SENT TO YOU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376566 VENFLON PRO 1.1MM X 32MM INTERVASCULAR CATHETER FOZ BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1