BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO SAFETY 18GA 1.3MM OD 45MM L

    MDR report key: 11527856 · Received March 19, 2021

    Report

    Report Number
    8041187-2021-00199
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 23, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 0171276, D4: MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, H4: DEVICE MANUFACTURE DATE: 2020-06-19. D4: MEDICAL DEVICE LOT #: 0171274, D4: MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, H4: DEVICE MANUFACTURE DATE: 2020-06-17. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-26. H6: INVESTIGATION SUMMARY: FOUR PHOTOS, THREE USED SAMPLES (TWO FROM BATCH 0171276 AND ONE FROM BATCH 0171274), 157 REPRESENTATIVE SAMPLES FROM BATCH 0171276 AND 61 REPRESENTATIVE SAMPLES FROM BATCH 0171274 WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE PHOTOS, IT WAS OBSERVED THAT THE VALVE HAD MOVED. THE REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION AND THE INJECTION LEAK TEST, ALL SAMPLES PASSED INSPECTION AND NO ABNORMALITIES WERE OBSERVED. UPON VISUAL INSPECTION OF THE USED SAMPLES, IT WAS OBSERVED THAT THE VALVE HAD MOVED TOWARDS THE LUER SIDE. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THE LEAKAGE IS DUE TO THE VALVE ISSUE. BD IS AWARE OF THIS ISSUE AND IS IN THE PROCESS OF IMPLEMENTING CORRECTIVE ACTIONS TO IMPROVE THE CUSTOMER AND PATIENT EXPERIENCE. CAPA 1379444 HAS BEEN INITIATED. THIS EVENT HAS BEEN ADDED TO OUR COMPLAINT DATABASE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON PRO SAFETY 18GA 1.3MM OD 45MM L LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE THROUGH INJECTION PORT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PRO SAFETY 18GA 1.3MM OD 45MM L LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE THROUGH INJECTION PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425151 VENFLON PRO SAFETY 18GA 1.3MM OD 45MM L CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1