BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 11665626 · Received April 14, 2021

    Report

    Report Number
    8041187-2021-00278
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 9, 2021
    Report Date
    May 26, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/21/2021. H.6. INVESTIGATION: TWENTY REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. TEN SAMPLES WERE FROM BATCH 0144811, NINE SAMPLES WERE FROM BATCH 0270634, AND ONE SAMPLE FROM BATCH 0051728. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, INJECTION LEAK TEST, AND CATHETER ADAPTER LEAK TEST. THE SAMPLES PASSED ALL 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 RETURNED STATEMENT, THE ROOT CAUSE OF THE LEAKAGE IS DUE TO THE VALVE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ORANGE VENFLON REF: 393230 LOT NO: 0144811P41 EXP: 2023-05-31 GREY VENFLON REF: 393229 LOT NO: 0144807P41 EXP: 2023-05-31 THE ISSUE WITH BOTH OF THESE IS WHEN FLUID IS PUT THROUGH IT LEAKS FROM BOTH SIDES OF THE VENFLON."

    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 SHIELDED IV CATHETER LEAKED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ORANGE VENFLON REF: 393230 LOT NO: 0144811P41 EXP: 2023-05-31. GREY VENFLON REF: (B)(4) LOT NO: 0144807P41 EXP: 2023-05-31. THE ISSUE WITH BOTH OF THESE IS WHEN FLUID IS PUT THROUGH IT LEAKS FROM BOTH SIDES OF THE VENFLON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561438 BD VENFLON PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0144811

    Patients

    Seq Age Sex Outcome Treatment
    1