BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 11697058 · Received April 20, 2021

    Report

    Report Number
    8041187-2021-00317
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 19, 2021
    Report Date
    May 28, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    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

    H.6. INVESTIGATION: TWENTY REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. 10 SAMPLES WERE RECEIVED FROM BATCH 0144811, FIVE SAMPLES WERE RECEIVED FROM BATCH 0270634, 3 SAMPLES WERE RECEIVED FROM BATCH 0051728, AND TWO SAMPLES FROM BATCH 0144807. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, INJECTION LEAK TEST, AND THE CATHETER ADAPTER LEAK TEST. ALL SAMPLES PASSED INSPECTION AND NO ABNORMALITIES WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THESE BATCHES. BASED ON THE CUSTOMER VERBATIM, THE ROOT CAUSE OF THE LEAKAGE COULD BE DUE TO THE VALVE ISSUE. CAPA#1379444 WAS INITIATED. : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALSO WE HAVE NOW HAD THE SAME ISSUE WITH 2 MORE DIFFERENT LOT NUMBERS".

    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 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALSO WE HAVE NOW HAD THE SAME ISSUE WITH 2 MORE DIFFERENT LOT NUMBERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594925 BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0270634

    Patients

    Seq Age Sex Outcome Treatment
    1