BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 12828000 · Received November 17, 2021

    Report

    Report Number
    8041187-2021-00981
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 19, 2021
    Report Date
    December 2, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1202862; MEDICAL DEVICE EXPIRATION DATE: 2024-07-31; DEVICE MANUFACTURE DATE: 2021-09-29. MEDICAL DEVICE LOT #: 1175159; MEDICAL DEVICE EXPIRATION DATE: 2024-06-30; DEVICE MANUFACTURE DATE: 2021-07-30. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVAL?: YES. D9. RETURNED TO MANUFACTURER ON: 11/22/2021. H6. INVESTIGATION: TWO SAMPLES AND TWO TOP WEB LABELS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED ON THE TWO USED SAMPLES. NO ABNORMALITIES WERE FOUND ON THE SURFACE OF THE CATHETER. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER EACH FROM LOTS 1202862 AND 1175159 WERE DEFECTIVE AND COULD NOT BE TUNNELED INTO THE PATIENT'S VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "DURING A PERIPHERAL CATHETER INSERTION, IT WAS IMPOSSIBLE "TO TUNNEL" THE VEIN, BECAUSE OF THE PRESENCE OF SWELLING ON THE CATHETER. THE PROCEDURE WAS PERFORMED A SECOND TIME WITH ANOTHER CATHETER: FAILURE FOR THE SAME REASON. THE PROCEDURE WAS PERFORMED A THIRD TIME. CLINICAL CONSEQUENCES OBSERVED MULTIPLICATION OF INVASIVE PROCEDURES ON THE PATIENT ON MULTIPLE OCCASIONS. DELAY IN PATIENT MANAGEMENT. CONSERVATIVE MEASURES AND ACTIONS TAKEN WITHDRAWAL OF THE CATHETER AND USE OF ANOTHER OF THE SAME REFERENCE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER EACH FROM LOTS 1202862 AND 1175159 WERE DEFECTIVE AND COULD NOT BE TUNNELED INTO THE PATIENT'S VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "DURING A PERIPHERAL CATHETER INSERTION, IT WAS IMPOSSIBLE "TO TUNNEL" THE VEIN, BECAUSE OF THE PRESENCE OF SWELLING ON THE CATHETER. THE PROCEDURE WAS PERFORMED A SECOND TIME WITH ANOTHER CATHETER: FAILURE FOR THE SAME REASON. THE PROCEDURE WAS PERFORMED A THIRD TIME. CLINICAL CONSEQUENCES OBSERVED MULTIPLICATION OF INVASIVE PROCEDURES ON THE PATIENT ON MULTIPLE OCCASIONS. DELAY IN PATIENT MANAGEMENT. CONSERVATIVE MEASURES AND ACTIONS TAKEN WITHDRAWAL OF THE CATHETER AND USE OF ANOTHER OF THE SAME REFERENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730764 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown