BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 11379180 · Received February 25, 2021

    Report

    Report Number
    8041187-2021-00126
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 1, 2021
    Report Date
    May 18, 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: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-03-03 H6: INVESTIGATION SUMMARY ONE REPRESENTATIVE SAMPLE AND USED SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE USED SAMPLE IT WAS OBSERVED THAT THE VALVE HAD MOVED. THE REPRESENTATIVE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION, INJECTION LEAK TEST AND THE CATHETER ADAPTER LEAK TEST AND NO ABNORMALITIES WERE OBSERVED. 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. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER LEAKED FLUID PAST THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "A FLUID LEAK OCCURRED AT THE GRAY CAP. SIMILAR EVENT AS FOR THE TWO NUMBERS 00776/21 AND 00940/21. ALSO IN THIS CASE THE INJECTION VALVE IS DEFECTIVE FOR THE SAME BATCH NUMBER. THIS IS PERMEABLE TO LIQUIDS IN BOTH DIRECTIONS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER LEAKED FLUID PAST THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "A FLUID LEAK OCCURRED AT THE GRAY CAP. SIMILAR EVENT AS FOR THE TWO NUMBERS 00776/21 AND 00940/21. ALSO IN THIS CASE THE INJECTION VALVE IS DEFECTIVE FOR THE SAME BATCH NUMBER. THIS IS PERMEABLE TO LIQUIDS IN BOTH DIRECTIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275898 BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0153325

    Patients

    Seq Age Sex Outcome Treatment
    1