BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 11703880 · Received April 21, 2021

    Report

    Report Number
    8041187-2021-00325
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 15, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO PROVIDED TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. BASED ON THE VERBATIM, THE PROBABLE ROOT CAUSE FOR THE LEAKAGE COULD BE DUE TO VALVE ISSUE. CAPA#1379444 WAS INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER MEMBRANE CAME OFF AND BLOOD LEAKED OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUSHING THE ORANGE PVK INTO CHIMNEY/PORT WITH NACL. THE MEMBRANE COMES OFF AND BLOOD COMES OUT OF THE CHIMNEY. INSPECT THE PVK AND SEES THAT THE MEMBRANE HAS REVERSED BUT NOT ENTERED THE VESSEL."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER MEMBRANE CAME OFF AND BLOOD LEAKED OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUSHING THE ORANGE PVK INTO CHIMNEY/PORT WITH NACL. THE MEMBRANE COMES OFF AND BLOOD COMES OUT OF THE CHIMNEY. INSPECT THE PVK AND SEES THAT THE MEMBRANE HAS REVERSED BUT NOT ENTERED THE VESSEL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598822 BD VENFLON PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1