BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L

    MDR report key: 9070467 · Received September 16, 2019

    Report

    Report Number
    8041187-2019-00724
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 30, 2019
    Report Date
    September 3, 2019
    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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: 2 PHOTOS WERE RETURNED FOR INVESTIGATION. NO SAMPLE HAS BEEN RETURNED. INVESTIGATION CONCLUSION: 2 PHOTOS WERE RETURNED FOR INVESTIGATION. THE 1ST AND 2ND PHOTOS SHOW THE LEAKAGE IN BETWEEN THE NEEDLE HUB AND FLOW CONTROL PLUG WAS OBSERVED. THE 1ST PHOTO ALSO SHOWS THE TOP WEB WITH BATCH #9140613. ABLE TO CONFIRM THE CUSTOMER EXPERIENCE. ROOT CAUSE DESCRIPTION: LEAKAGE IN BETWEEN THE NEEDLE HUB AND FLOW CONTROL PLUG WAS OBSERVED FROM THE PHOTOS RETURNED. MOLDING PROCESS (MATERIAL): THERE COULD BE A MOLDING DEFECT ON THE NEEDLE HUB MATERIAL OR THE FLOW CONTROL PLUG (FCP) MATERIAL. WHEN THE TWO PARTS ARE ASSEMBLED, THERE COULD BE GAP IN BETWEEN NEEDLE HUB AND FCP THAT COULD RESULT IN LEAKAGE. HOWEVER, AS THE ACTUAL SAMPLE WAS NOT RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED. ASSEMBLY PROCESS: THE ASSEMBLY PROCESS HAS BEEN REVIEWED. THERE COULD BE DAMAGE TO THE NEEDLE HUB OR FCP DURING ASSEMBLY OR THERE COULD BE IMPROPER ASSEMBLY DURING PRODUCTION WHICH CAUSE THE TWO PARTS NOT BEING ABLE TO ASSEMBLE PROPERLY. HOWEVER, THE DHR WAS REVIEWED AND THERE WAS NO ABNORMALITY BEING RECORDED DURING THE PRODUCTION OF THIS BATCH. AS THE ACTUAL SAMPLE WAS NOT RETURNED, NO INVESTIGATION COULD BE PERFORMED. THEREFORE THE ROOT CAUSE CANNOT BE DETERMINED. PRODUCT APPLICATION: THE OTHER PROBABLE CAUSE WOULD BE DURING PRODUCT APPLICATION. THE USER COULD HAD HELD THE INCORRECT POSITION DURING WITHDRAWAL AND UNINTENTIONALLY WITHDRAWN THE NEEDLE BY GRIPPING THE FCP INSTEAD OF THE NEEDLE HUB. THIS LOOSEN THE FCP AND CAUSE THE LEAKAGE TO HAPPEN. AS IT IS NOT POSSIBLE TO PERFORM FURTHER INVESTIGATION BASED ON THE PHOTOS RETURN, THE PROBABLE ROOT CAUSE REMAINS ONLY A HYPOTHESIS. THE ACTUAL SAMPLE WOULD BE REQUIRED FOR INVESTIGATION TO CONFIRM THE ACTUAL ROOT CAUSE. RATIONALE: NO SAMPLE WAS RETURNED FOR INVESTIGATION. THE COMPLAINT TREND WILL BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L EXPERIENCED LEAKAGE AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INJECTION AND RETRACTING THE NEEDLE THERE WAS A LEAKAGE OF BLOOD, A DROP, AT THE CONNECTION WITH THE 'END PIECE'. THIS IS ALREADY THE 2ND TIME IN THIS MONTH!! AND WITH DIFFERENT LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866739 VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L INTERVASCULAR CANNULA FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9140613

    Patients

    Seq Age Sex Outcome Treatment
    1 Other