BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER

    MDR report key: 16289052 · Received February 3, 2023

    Report

    Report Number
    8041187-2023-00043
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 13, 2023
    Report Date
    March 28, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903932245
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2203272. MEDICAL DEVICE EXPIRATION DATE: 31JUL2025. DEVICE MANUFACTURE DATE: 11AUG2022. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION H5: IMDRF ANNEX A GRID: A0510. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 30-JAN-2023. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 10 REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF NEEDLE RETRACTION FAILURE WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THAT THE V-CLIP WAS DEFORMED. THE LATCH OF THE V-CLIP DID NOT FULLY RETRACT IN THE NEEDLE CAP AFTER THE NEEDLE WAS REMOVED, TENTATIVELY CAUSING THE NEEDLE CAP TO HAVE DIFFICULTY DETACHING FROM CANNULA HUB. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS DUE TO THE MISALIGNMENT OF THE V-CLIP PICK AND PLACE STATION. BASED ON THE INVESTIGATION, THE LOOSE/STRAY V-CLIP COULD BE ACCIDENTALLY TRANSFERRED BY HUMAN/TOOLS AND GET STUCK IN CYLINDER BLOCK WHICH CAUSED THE V-CLIP NEST TO MOVE OUT OF ITS ORIGINAL HOME POSITION. THE MISS-POSITIONING OF ESCAPEMENT NEST RESULTED IN MISALIGNMENT WITH THE V-CLIP INSERTION TOOL AND DAMAGED THE V-CLIP. ACTIONS HAVE BEEN PLANNED TO PREVENT THE RECURRENCE OF THIS FAILURE. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER THE NEEDLE FAILED TO RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WHEN TAKING OUT THE NEEDLE, IT STAYS VERY CLAMPED. WE HAD TO FIX THE INFUSION (HOLD IT VERY FIRMLY), IN ORDER NOT TO PULL OUT THE INFUSION SYSTEM AT THE SAME TIME AS TAKING OUT THE NEEDLE. NOT ALL OF THEM HAVE IT. BUT A FEW ALSO STICK.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER THE NEEDLE FAILED TO RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WHEN TAKING OUT THE NEEDLE, IT STAYS VERY CLAMPED. WE HAD TO FIX THE INFUSION (HOLD IT VERY FIRMLY), IN ORDER NOT TO PULL OUT THE INFUSION SYSTEM AT THE SAME TIME AS TAKING OUT THE NEEDLE. NOT ALL OF THEM HAVE IT. BUT A FEW ALSO STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935497 BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER INTRAVASCUALR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2173267 00382903932245

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown