BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 11498513 · Received March 16, 2021

    Report

    Report Number
    8041187-2021-00189
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 18, 2021
    Report Date
    May 27, 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: 2021-03-26. H6: INVESTIGATION SUMMARY FOUR PHOTOS, THREE USED SAMPLES (TWO FROM BATCH 0171276 AND ONE FROM BATCH 017274), 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETERS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE LAST TWO WEEKS WE RECEIVE TWO REPORTS FROM THE ANESTHESIA DEPARTMENT REGARDING BD VENFLON PRO SAFETY 18 G. IN BOTH CASES, INFUSION LEAKED THROUGH THE INJECTION PORT. ALREADY IN NOVEMBER MY COLLEAGUE REPORTED A SIMILAR CASE, A DIFFERENT LOT WAS AFFECTED.

    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 2 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETERS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE LAST TWO WEEKS WE RECEIVE TWO REPORTS FROM THE ANESTHESIA DEPARTMENT REGARDING BD VENFLON PRO SAFETY 18 G. IN BOTH CASES, INFUSION LEAKED THROUGH THE INJECTION PORT. ALREADY IN NOVEMBER MY COLLEAGUE REPORTED A SIMILAR CASE, A DIFFERENT LOT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395802 BD VENFLON PRO SAFETY SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0171274

    Patients

    Seq Age Sex Outcome Treatment
    1