BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9832598 · Received March 14, 2020

    Report

    Report Number
    8041187-2020-00146
    Event Type
    Malfunction
    Date Received
    March 14, 2020
    Date of Event
    February 20, 2020
    Report Date
    March 25, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKED OUT OF THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER'S CONTROL PLUG DURING USE. THE PATIENT HAD A "GREEN PVK" ON THEIR LEFT WRIST AND WAS RECEIVING "4 ML OF INFUSION FLUID" WHEN BLOOD LEAKED AS THE PORT WAS OPENED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT HAD A GREEN PVK ON LEFT WRIST. 4 ML OF INFUSION FLUID WAS ADMINISTERED VIA PVK, FROM THEIR "DESCRIPTION" IT SEEMS TO HAVE BEEN DONE VIA THE PORT. WHEN THE PORT WAS OPENED, IT STARTED BLEEDING FROM THE PORT. THEY CLAIM THE "FILTER/BACK CHECK VALVE" WAS RUINED AT ADMINISTRATION. THIS WAS MAYBE THE 10TH TIME THE USED THE PORT FOR ADDING DRUGS TO THE PATIENT.... THEY DESCRIBE THIS AS A SERIOUS EVENT, AND POSSIBLE PRODUCTION FAULT. SUCH A FAULT CAN CAUSE BLEEDING NOT DISCOVERED BY THE NURSE/DOCTOR, AS THE PATIENT IS COVERED UP IN THE OR. WHEN USING HEPARIN OR SIMILAR DRUGS THIS COULD CAUSE FURTHER DAMAGE. THEY HAVE SEEN THIS ALSO ON A GREY CANNULA FROM BD. "

    Additional Manufacturer Narrative · 1

    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 BLOOD LEAKED OUT OF THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER'S CONTROL PLUG DURING USE. THE PATIENT HAD A "GREEN PVK" ON THEIR LEFT WRIST AND WAS RECEIVING "4 ML OF INFUSION FLUID" WHEN BLOOD LEAKED AS THE PORT WAS OPENED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT HAD A GREEN PVK ON LEFT WRIST. 4 ML OF INFUSION FLUID WAS ADMINISTERED VIA PVK, FROM THEIR DESCRIPTION IT SEEMS TO HAVE BEEN DONE VIA THE PORT. WHEN THE PORT WAS OPENED, IT STARTED BLEEDING FROM THE PORT. THEY CLAIM THE "FILTER/BACK CHECK VALVE" WAS RUINED AT ADMINISTRATION. THIS WAS MAYBE THE 10TH TIME THE USED THE PORT FOR ADDING DRUGS TO THE PATIENT.... THEY DESCRIBE THIS AS A SERIOUS EVENT, AND POSSIBLE PRODUCTION FAULT. SUCH A FAULT CAN CAUSE BLEEDING NOT DISCOVERED BY THE NURSE/DOCTOR, AS THE PATIENT IS COVERED UP IN THE OR. WHEN USING HEPARIN OR SIMILAR DRUGS THIS COULD CAUSE FURTHER DAMAGE. THEY HAVE SEEN THIS ALSO ON A GREY CANNULA FROM BD. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296550 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other