BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 9834023 · Received March 16, 2020

    Report

    Report Number
    8041187-2020-00145
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 18, 2020
    Report Date
    April 6, 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 SUMMARY: TWO REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. BOTH SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, VALVE INJECTION TEST AND CATHETER ADAPTER LEAK TEST. BOTH SAMPLES PASSED THE INSPECTION CRITERIA AND NO LEAKAGE WAS OBSERVED; THEREFORE, THE INCIDENT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE INVESTIGATION OF THE SAMPLES PROVIDED AN ACTUAL ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE VERBATIM DESCRIPTION, THE PROBABLE ROOT CAUSE OF THE LEAKAGE COULD BE DUE TO VALVE MOVED WITHIN THE CANNULA HUB. CAPA#1379444 HAS BEEN INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER'S CONTROL PLUG DURING USE. THE PATIENT WAS BEING PREPARED FOR A 3 HOUR SURGERY" IN THE OPERATION ROOM, AND A "GREY PVK" WAS PLACED IN THE RIGHT ARM. "500 ML" OF "RINGER ACETAT" WAS INFUSED, AND ANESTHESIA WAS STARTED BY INSERTING DRUGS VIA THE PVK PORT. BLOOD RETURN WAS NOTICED IN THE CANNULA, AND BLOOD LEAKED FROM THE PORT. THE INFUSION WAS STOPPED AND THE VEIN OCCLUDED BY MANUAL PRESSURE WHILE THE PVK WAS REMOVED. INSPECTING THE CATHETER AFTER BY COMPARING IT TO AN UNUSED ONE SHOWED THE "MEMBRANE IN THE PORT" WAS "DISPLACED". LOT#'S 9281169 AND 9080793 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT IS BEING PREPARED FOR ABC OPERATION AND IS IN THE OR. GREY PVK PLACED IN RIGHT ARM, AT ELBOW. AN. NURSE DOING THE PVK MAKES NO SPECIAL REMARKS. AN INFUSION WITH 500 ML RINGER ACETAT IS STARTED. THEN THE AN. DOCTOR STARTS ANESTHESIA BY INSERTING DRUGS VIA THE PORT ON THE PVK. THE DOCTOR QUICKLY DISCOVERS THAT THERE IS BLOOD RETURN IN THE CANNULAE, AND BLOOD IS COMING OUR OF THE PORT. THE INFUSION IS STOPPED, THE VEIN IS OCCLUDED BY MANUAL PRESSURE, AND THE PVK IS REMOVED. WHEN MANUALLY INSPECTING THE REMOVED CATHETER, AND COMPARING IT WITH AN UNUSED CATHETER, IT LOOKS LIKE THE MEMBRANE IN THE PORT IS DISPLACED, SO THE BLOOD IS NOT STOPPED LIKE NORMAL. THIS COULD HAVE HAD CONSEQUENCES FOR THE PATIENT. UNDER THE OR COVERS THEY WOULD NOT HAVE SEEN THE BLEEDING, AND THE OPERATION WAS A 3 HOUR SURGERY."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9281169. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2019-10-08. MEDICAL DEVICE LOT #: 9080793. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2019-04-09. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER'S CONTROL PLUG DURING USE. THE PATIENT WAS BEING PREPARED FOR A 3 HOUR SURGERY" IN THE OPERATION ROOM, AND A "GREY PVK" WAS PLACED IN THE RIGHT ARM. "500 ML" OF "RINGER ACETAT" WAS INFUSED, AND ANESTHESIA WAS STARTED BY INSERTING DRUGS VIA THE PVK PORT. BLOOD RETURN WAS NOTICED IN THE CANNULA, AND BLOOD LEAKED FROM THE PORT. THE INFUSION WAS STOPPED AND THE VEIN OCCLUDED BY MANUAL PRESSURE WHILE THE PVK WAS REMOVED. INSPECTING THE CATHETER AFTER BY COMPARING IT TO AN UNUSED ONE SHOWED THE "MEMBRANE IN THE PORT" WAS "DISPLACED". LOT#'S 9281169 AND 9080793 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT IS BEING PREPARED FOR ABC OPERATION AND IS IN THE OR. GREY PVK PLACED IN RIGHT ARM, AT ELBOW. AN. NURSE DOING THE PVK MAKES NO SPECIAL REMARKS. AN INFUSION WITH 500 ML RINGER ACETAT IS STARTED. THEN THE AN. DOCTOR STARTS ANESTHESIA BY INSERTING DRUGS VIA THE PORT ON THE PVK. THE DOCTOR QUICKLY DISCOVERS THAT THERE IS BLOOD RETURN IN THE CANNULAE, AND BLOOD IS COMING OUR OF THE PORT. THE INFUSION IS STOPPED, THE VEIN IS OCCLUDED BY MANUAL PRESSURE, AND THE PVK IS REMOVED. WHEN MANUALLY INSPECTING THE REMOVED CATHETER, AND COMPARING IT WITH AN UNUSED CATHETER, IT LOOKS LIKE THE MEMBRANE IN THE PORT IS DISPLACED, SO THE BLOOD IS NOT STOPPED LIKE NORMAL. THIS COULD HAVE HAD CONSEQUENCES FOR THE PATIENT. UNDER THE OR COVERS THEY WOULD NOT HAVE SEEN THE BLEEDING, AND THE OPERATION WAS A 3 HOUR SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297878 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 Other