BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9416308 · Received December 5, 2019

    Report

    Report Number
    8041187-2019-00982
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    October 9, 2019
    Report Date
    March 24, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 1 PHOTO, 16 USED SAMPLES, AND 205 REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE RETURNED PHOTO SHOWS LEAKAGE FROM THE PRODUCT AFTER INSERTION ON PATIENT'S HAND. THE 16 USED SAMPLES WERE SUBJECT TO VISUAL INSPECTION, CATHETER ADAPTER LEAK TEST AND END CAP LEAK TEST. 3 OF THE USED SAMPLES DID NOT HAVE AN END CAP RETURNED. THE REMAINING 13 SAMPLES WERE SUBJECTED TO THE END CAP LEAK TEST AND ALL 13 SAMPLES PASSED THE END CAP LEAK TEST. THE 16 USED SAMPLES WERE THEN SUBJECTED TO CATHETER ADAPTER LEAK TEST. 1 OF THE USED SAMPLES FAILED THE CATHETER ADAPTER LEAK TEST. UPON VISUAL INSPECTION, FOREIGN MATTER WAS OBSERVED IN THE INJECTION PORT OF THE SAMPLE. AS FOREIGN MATTER IS NOT THE REPORTED DEFECT OF THIS COMPLAINT AND THE SAMPLE IS A USED SAMPLE, THE FOREIGN MATTER COULD HAD BEEN INTRODUCED DURING FROM PRODUCT USAGE. THEREFORE NO FURTHER ANALYSIS WAS PERFORMED ON THE FOREIGN MATTER. FROM THE SIDE VIEW OF THE INJECTION PORT, THE FOREIGN MATTER WAS OBSERVED TO BE STUCK BETWEEN THE VALVE AND THE WALL OF THE CANNULA HUB. THIS COULD HAD PREVENTED THE VALVE FROM CLOSING PROPERLY AND LEAD TO THE LEAKAGE FROM THE VALVE. THE 205 REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, VALVE INJECTION LEAK TEST, CATHETER ADAPTER LEAK TEST AND END CAP LEAK TEST. THE GRAY VALVE MOVED WAS OBSERVED IN ONE OF THE REPRESENTATIVE SAMPLES AND LEAKAGE WAS OBSERVED FROM THE INJECTION PORT. END CAP LEAKAGE WAS OBSERVED ON 3 OUT OF 205 REPRESENTATIVE SAMPLES. THE 3 REPRESENTATIVE SAMPLES WERE THEN FURTHER SUBJECTED TO END CAP CONE MEASUREMENT. ALL THE 3 SAMPLES FAILED. THE OVER-SIZED CAP COULD HAVE CAUSED THE END CAP NOT BE ABLE TO SECURE PROPERLY ON THE CANNULA HUB LUER AND LEAD TO THE LEAKAGE. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE INVESTIGATION, THE PROBABLE CAUSE OF THE LEAKAGE FROM THE INJECTION PORT COULD BE DUE TO VALVE MOVING WITHIN THE CANNULA HUB. A TREND FOR THE MOVING INJECTION VALVE HAS BEEN OBSERVED FOR THIS PRODUCT LINE. CAPA 1379444 HAS BEEN STARTED TO FURTHER DETERMINE THE REASON FOR THE MOVING INJECTION VALVE IN THE VENFLON PRO SAFETY SO THAT A FIX CAN BE MADE TO FURTHER PREVENT THIS ISSUE. AS FOR THE LEAKAGE AT THE END CAP, THE OVERSIZED CAP COULD BE DUE TO WEAR AND TEAR OF MOLD INSERT WHICH RESULTS IN BIGGER DIAMETER BEING MOLDED AND LEADS TO A BULGED CONE. THE BULGED CONE COULD HAVE PREVENTED THE CANNULA HUB FROM SLIPPING ONTO THE LUER PROPERLY AND CAUSED THE LEAKAGE FROM THE END CAP AS THE USER WOULD NOT BE ABLE TO TIGHTEN PROPERLY. CUSTOMER COMPLAINT TRENDS WILL ALSO CONTINUE TO BE EVALUATED ON A MONTHLY BASIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE LEAKAGE OCCURRED AT THE PORTSIDE AND AT THE CAP WITH A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE AT PORTSIDE AND AT THE END CAP.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9167755. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2019-06-16. MEDICAL DEVICE LOT #: 9241117. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2019-08-29." INITIAL REPORTER PHONE #: UNKNOWN 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 DURING USE LEAKAGE OCCURRED AT THE PORTSIDE AND AT THE CAP WITH A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE AT PORTSIDE AND AT THE END CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215726 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other