BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PERIPHERAL PORTED IV CATHETER

    MDR report key: 14622817 · Received June 7, 2022

    Report

    Report Number
    2243072-2022-00766
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 9, 2022
    Report Date
    June 15, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(6). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED., AND (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY- THE SAMPLES WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED SAMPLES OF 16 VENFLON 2 PINK 20GA IV CANNULA FROM LOT # 1162921 PRODUCT # 391452 WITH THE REPORTED COMPLAINT OF CAP LOOSE. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR CAP LOOSE AND NO CAP LOOSE WAS FOUND IN THE TEN RETENTION SAMPLES. THE 16 RECEIVED SAMPLES WERE VISUALLY TESTED FOR LOOSE CAP AND NONE OF THEM SHOWED ANY LOOSE CAP IN THEM. THE RETURNED SAMPLES WERE ALSO TESTED FOR PROTECTION CAP DISASSEMBLY FORCE, AND IT WAS FOUND TO BE WITHIN BD SPECIFICATIONS. THERE WAS NO DEFECT FOUND IN THE RETURNED SAMPLES. THE DEFECT COULD NOT BE CONFIRMED. THERE IS NO PROBABLE ROOT CAUSE IDENTIFIED FOR THE REPORTED DEFECT AS THERE IS NOT DEFECT FOUND IN THE RETURNED SAMPLES. THE DHR OF MATERIAL NO. 391452 WITH BATCH NO. 1162921 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT NO. FROM ITS PRODUCTION DATE TO ITS DISPATCH ON DATE THERE IS NO ACTION TAKEN AS THERE IS NO DEFECT FOUND AND NO PROBABLE ROOT CAUSE IDENTIFIED ON THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF ADDITIONAL SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VENFLON¿ PERIPHERAL PORTED IV CATHETER THE PORT CAP IS DEFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLUE LID IS SLANTED, AND CANNOT BE TURNED, THEREFORE IT IS NOT SUITABLE FOR FIXING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VENFLON¿ PERIPHERAL PORTED IV CATHETER THE PORT CAP IS DEFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLUE LID IS SLANTED, AND CANNOT BE TURNED, THEREFORE IT IS NOT SUITABLE FOR FIXING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577848 BD VENFLON¿ PERIPHERAL PORTED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 1162921

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown