BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L

    MDR report key: 10775283 · Received November 2, 2020

    Report

    Report Number
    8041187-2020-00706
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 12, 2020
    Report Date
    December 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. FROM THE VERBATIM, THE PROBABLE ROOT CAUSE FOR THE LEAKAGE COULD BE DUE TO VALVE ISSUE. CAPA# 1379444 HAS BEEN INITIATED TO ADDRESS THE ISSUE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DETAILS OF INCIDENT / NATURE OF DEVICE DEFECT TEST THE DATIX INCIDENT FORM STSTES: "PATIENT HAD A 14G IV CANNULA INSERTED IN THE LEFT HAND PRIOR TO AORTIC SURGERY. THE CANNULA WAS INSERTED WITHOUT INCIDENT AND USED TO INJECT MEDICATION. AROUND 30 MINS LATER IT WAS NOTED THE CANNULA BLEEDING THROUGH THE INJECTION PORT THIS IS THE 4TH INCIDENT THAT I AM AWARE OF WITH THESE 14G CANNULAE FORTUNATELY THIS WAS DETECTED PRIOR TO THE PATIENT BEING DRAPED AND HEPARINISED. THIS COULD HAVE CAUSED A SERIOUS AMOUNT OF BLOOD LOSS THAT WOULD NOT BE DETECTABLE FOR SOME TIME " DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): MINOR BLOOD LOSS - NO INJURY OR HARM ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER) FAULTY DEVICE REMOVED AND QUARANTINED WITH PACKAGING. YELLOW CARD REPORTS HAVE PREVIOUSLY BEEN SUBMITTED HIGHLIGHTING THIS PROBLEM. THE RESPONSE FROM BD TO MHRA REF:2020/001/013/401/020 CONCLUDED: "BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THE LEAKAGE IS DUE TO THE INJECTION VALVE MOVING WITHIN THE CANNULA HUB. A TREND FOR THE MOVING INJECTION VALVE HAS BEEN OBSERVED FOR THIS PRODUCT LINE. A PROJECT HAS BEEN STARTED TO FURTHER DETERMINE THE REASON FOR THE MOVING INJECTION VALVE IN THE VENFLON PRO SAFETY SO THAT A FIX CAN BE MADE TO FURTHER PREVENT THIS ISSUE." HAS ANY PROGRESS BEEN MADE TO RESOLVE THIS DESIGN FAULT?"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). INITIAL REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENFLON PRO SAFETY 14 GA 2.0 MM OD 45 MM L LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DETAILS OF INCIDENT / NATURE OF DEVICE DEFECT TEST THE DATIX INCIDENT FORM STATES: "PATIENT HAD A 14G IV CANNULA INSERTED IN THE LEFT HAND PRIOR TO AORTIC SURGERY. THE CANNULA WAS INSERTED WITHOUT INCIDENT AND USED TO INJECT MEDICATION. AROUND 30 MINS LATER IT WAS NOTED THE CANNULA BLEEDING THROUGH THE INJECTION PORT THIS IS THE 4TH INCIDENT THAT I AM AWARE OF WITH THESE 14G CANNULAE FORTUNATELY THIS WAS DETECTED PRIOR TO THE PATIENT BEING DRAPED AND HEPARINISED. THIS COULD HAVE CAUSED A SERIOUS AMOUNT OF BLOOD LOSS THAT WOULD NOT BE DETECTABLE FOR SOME TIME " DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): MINOR BLOOD LOSS: NO INJURY OR HARM ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER) FAULTY DEVICE REMOVED AND QUARANTINED WITH PACKAGING. YELLOW CARD REPORTS HAVE PREVIOUSLY BEEN SUBMITTED HIGHLIGHTING THIS PROBLEM. THE RESPONSE FROM BD TO (B)(6) CONCLUDED: "BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THE LEAKAGE IS DUE TO THE INJECTION VALVE MOVING WITHIN THE CANNULA HUB. A TREND FOR THE MOVING INJECTION VALVE HAS BEEN OBSERVED FOR THIS PRODUCT LINE. A PROJECT HAS BEEN STARTED TO FURTHER DETERMINE THE REASON FOR THE MOVING INJECTION VALVE IN THE VENFLON PRO SAFETY SO THAT A FIX CAN BE MADE TO FURTHER PREVENT THIS ISSUE." HAS ANY PROGRESS BEEN MADE TO RESOLVE THIS DESIGN FAULT?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238771 VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9241670

    Patients

    Seq Age Sex Outcome Treatment
    1