BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9833937 · Received March 16, 2020

    Report

    Report Number
    8041187-2020-00143
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 17, 2020
    Report Date
    April 23, 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: FIVE REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE FIVE REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, VALVE INJECTION TEST AND CATHETER ADAPTER LEAK TEST. ALL FIVE PASSED THE INSPECTION CRITERIA AND NO LEAKAGE WAS OBSERVED; THEREFORE, THE INCIDENT COULD NOT BE VERIFIED. 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. SINCE THE SAMPLES PASSED THE INSPECTION CRITERIA, A ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. AS THE REPRESENTATIVE SAMPLES PASSED THE INSPECTION CRITERIA, THE REPORTED CONDITION CANNOT BE DETERMINED. A REVIEW OF PAST 12 MONTHS QUALITY NOTIFICATION WAS PERFORMED. NO SIMILAR QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED DEFECT. COMPLAINT WILL BE REOPENED WHEN THE ACTUAL SAMPLE IS RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE REMAINDER OF THE "60 ML" SUBCUTANEOUS LIQUID LEAKED FROM THE CLOSED PORT OF THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER DURING USE WHEN THE PATIENT'S VEIN BURST. LOT#'S 9241521, 9241534, AND 9264937 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: "DURING ADMINISTRATION OF CONTRAST THE FLUID WENT SUBCUTANEOUS. 60 ML WENT SUBCUTANEOUS BECAUSE THE PATIENT'S VEIN BURST, THE REMAINING 60 ML CAME OUT OF THE PORT ON THE CATHETER. THE USER IS WONDERING IF THERE MIGHT BE A PRODUCTION FAULT SINCE FLUID CAME OUT OF THE CLOSED PORT."

    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 #: 9241521. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2019-08-29. MEDICAL DEVICE LOT #: 9241534. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2019-08-29. MEDICAL DEVICE LOT #: 9264937. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2019-09-21. 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 THE REMAINDER OF THE "60 ML" SUBCUTANEOUS LIQUID LEAKED FROM THE CLOSED PORT OF THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER DURING USE WHEN THE PATIENT'S VEIN BURST. LOT#'S 9241521, 9241534, AND 9264937 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: "DURING ADMINISTRATION OF CONTRAST THE FLUID WENT SUBCUTATEOUS. 60 ML WENT SUBCUTANEOUS BECAUSE THE PATIENT'S VEIN BURST, THE REMAINING 60 ML CAME OUT OF THE PORT ON THE CATHETER. THE USER IS WONDERING IF THERE MIGHT BE A PRODUCTION FAULT SINCE FLUID CAME OUT OF THE CLOSED PORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301574 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other