BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO

    MDR report key: 18965494 · Received March 23, 2024

    Report

    Report Number
    2243072-2024-00433
    Event Type
    Malfunction
    Date Received
    March 23, 2024
    Date of Event
    February 12, 2024
    Report Date
    August 22, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903932047
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    04 PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS OF VENFLON PRO 20G FROM LOT # 2101138 REGARDING ITEM #393204 WITH THE REPORTED ISSUE THAT PACKAGE SEAL INTEGRITY POOR / QUESTIONABLE. THE PHOTOS SHOWS THAT THE SEAL IS OPEN FROM THE LUER CAP END OF THE CATHETER. ONE PHOTO WITH 5 SAMPLES SHOWS 5-UNIT PACKS WITH SEAL OPEN, SECOND PHOTO SHOW 4 SAMPLES WITH UNIT PACK SEAL OPEN AGAIN FROM LUER CAP SIDE, THIRD AND FOURTH PHOTO SHOWS 1 SAMPLE EACH WHERE SEAL IS OPEN FROM LUER CAP SIDE OF UNIT PACK. THE INVESTIGATION WAS CARRIED OUT ON 25 RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY INSPECTED THE SAMPLES FOR PACKAGE SEAL INTEGRITY AND NO POOR / QUESTIONABLE PACKAGE SEAL INTEGRITY WAS FOUND IN THE 25 RETENTION SAMPLES. THE EXACT ROOT CAUSE CAN ONLY BE DETERMINED IF WE RECEIVE THE ORIGINAL SAMPLE.

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE OF PACKAGE SEAL INTEGRITY POOR/ QUESTIONABLE WAS CONFIRMED UPON INSPECTION OF THE PHOTOS. HOWEVER, BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO PHYSICAL SAMPLE WAS RETURNED. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE OF THE REPORTED FAILURE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    ADDRESS TAB E. TOO LONG: (B)(6). H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    CUSTOMER FOUND VENFLON PRO PACKAGING OPENED AT BOTTOM OF CANNULA. K2 IS A DISTRIBUTOR FOR BD SOUTH AFRICA. THEIR CUSTOMER FOUND THE PACKAGING OF THE VENFLON PRO WERE NOT SEALED, APPEARS PLASTIC HAS HARDENED AND PULLED AWAY FROM CLEAR UNIT CONTAINER. WE HAD A SIMILAR INCIDENT REF#(B)(4).

    Description of Event or Problem · 0

    CUSTOMER FOUND VENFLON PRO PACKAGING OPENED AT BOTTOM OF CANNULA. K2 IS A DISTRIBUTOR FOR BD SOUTH AFRICA. THEIR CUSTOMER FOUND THE PACKAGING OF THE VENFLON PRO WERE NOT SEALED, APPEARS PLASTIC HAS HARDENED AND PULLED AWAY FROM CLEAR UNIT CONTAINER. WE HAD A SIMILAR INCIDENT REF# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON PRO PACKAGE SEAL IS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND VENFLON PRO PACKAGING OPENED AT BOTTOM OF CANNULA. THEIR CUSTOMER FOUND THE PACKAGING OF THE VENFLON PRO WERE NOT SEALED, APPEARS PLASTIC HAS HARDENED AND PULLED AWAY FROM CLEAR UNIT CONTAINER. WE HAD A SIMILAR INCIDENT REF# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927734 BD VENFLON PRO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON 2101138 00382903932047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown