BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L

    MDR report key: 19480067 · Received June 6, 2024

    Report

    Report Number
    2243072-2024-00683
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 14, 2024
    Report Date
    July 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903932221
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION SUPPLEMENTAL MDR FOR CHANGES TO ANNEX E AND F CODES. THE REPRESENTATIVE SAMPLES PASSED THE VISUAL INSPECTION AND CATHETER TUBE TO CATHETER HUB UNION TEST (CATHETER PULL TEST). DHR WAS REVIEWED AND NO ABNORMALITY WAS OBSERVED. NO SIMILAR QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED DEFECT IN THE PAST 12 MONTHS. ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINT TREND WOULD BE CONTINUED TO BE TRACKED AND MONITORED.

    Additional Manufacturer Narrative · 0

    THE REPRESENTATIVE SAMPLES PASSED THE VISUAL INSPECTION AND CATHETER TUBE TO CATHETER HUB UNION TEST (CATHETER PULL TEST). DHR WAS REVIEWED AND NO ABNORMALITY WAS OBSERVED. NO SIMILAR QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED DEFECT IN THE PAST 12 MONTHS. ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINT TREND WOULD BE CONTINUED TO BE TRACKED AND MONITORED.

    Additional Manufacturer Narrative · 0

    CHANGE IN AR CODE. THE REPRESENTATIVE SAMPLES PASSED THE VISUAL INSPECTION AND CATHETER TUBE TO CATHETER HUB UNION TEST (CATHETER PULL TEST). DHR WAS REVIEWED AND NO ABNORMALITY WAS OBSERVED. NO SIMILAR QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED DEFECT IN THE PAST 12 MONTHS. ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINT TREND WOULD BE CONTINUED TO BE TRACKED AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L CATHETER BACKS OUT OF VEIN. WE HAVE A COMPLAINT TO REPORT REGARDING THE FOLLOWING DEVICE: INDWELLING VENOUS CANNULA VENFLON PROSAFETY 0,9X25MM 22G PZN (B)(6). QUANTITY (B)(4) PIECES. ORDER (B)(4). DELIVERY BILL TOG/725377 (ENCLOSED). REASON: CANNULA PUSHES OUT, CAUSING THE LIQUID TO RUN BACK. QUALITY DEFECT. WE CAN PROVIDE YOU WITH SAMPLES FOR TESTING (COLLECTION).

    Description of Event or Problem · 0

    WE HAVE A COMPLAINT TO REPORT REGARDING THE FOLLOWING DEVICE: (B)(6). INDWELLING VENOUS CANNULA VENFLON PROSAFETY 0,9X25MM 22G PZN (B)(4). QUANTITY (B)(4). LOT NUMBER 4010734 EXPIRY 31.12.2026 ORDER (B)(4). ORDER (B)(4). DELIVERY BILL (B)(4) (ENCLOSED). REASON: CANNULA PUSHES OUT, CAUSING THE LIQUID TO RUN BACK. QUALITY DEFECT. WE CAN PROVIDE YOU WITH SAMPLES FOR TESTING (COLLECTION).

    Description of Event or Problem · 0

    WE HAVE A COMPLAINT TO REPORT REGARDING THE FOLLOWING DEVICE: 393222. INDWELLING VENOUS CANNULA VENFLON PROSAFETY 0,9X25MM 22G PZN 11123935. QUANTITY (B)(4) PIECES. LOT NUMBER 4010734. EXPIRY 31.12.2026. ORDER (B)(4). ORDER (B)(4). DELIVERY BILL TOG/725377 (ENCLOSED). REASON: CANNULA PUSHES OUT, CAUSING THE LIQUID TO RUN BACK. QUALITY DEFECT. WE CAN PROVIDE YOU WITH SAMPLES FOR TESTING (COLLECTION).

    Description of Event or Problem · 0

    WE HAVE A COMPLAINT TO REPORT REGARDING THE FOLLOWING DEVICE: 393222. INDWELLING VENOUS CANNULA VENFLON PROSAFETY 0,9X25MM 22G, PZN 11123935, QUANTITY (B)(4) PIECES, LOT NUMBER 4010734, EXPIRY 31.12.2026, ORDER VT/BE0166404, ORDER (B)(4), DELIVERY BILL (B)(4) (ENCLOSED). REASON: CANNULA PUSHES OUT, CAUSING THE LIQUID TO RUN BACK. QUALITY DEFECT. WE CAN PROVIDE YOU WITH SAMPLES FOR TESTING (COLLECTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851008 BD VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 3307383 00382903932221

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown