BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ IV CANNULA

    MDR report key: 12544030 · Received September 28, 2021

    Report

    Report Number
    2243072-2021-02400
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 12, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿TWO VENFLON2 HAVE BEEN REMOVED FROM PATIENT DURING TO LEAKAGE FROM INJECTION PORT. THE LEAKAGE HAS BEEN FOUND AFTER INSERTION AND LEAKAGE HAS CONTINUED EVEN WITH PORT CLOSED WITH PRE-ATTACHED CLOSING DEVICE¿ WITH LOT NUMBER 0182212 REGARDING ITEM # 391451, SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE DHR OF MATERIAL NUMBER 391451 AND LOT NUMBER 0182212 WAS CHECKED AND NO QUALITY NOTIFICATION WAS RECORDED ON THIS LOT. NONE OF THE TEN RETENTION SAMPLES SHOWED LEAKAGE FROM PORT ON THEM. THE DEFECT COULD NOT BE CONFIRMED. AS NO PHOTOGRAPHS OR ORIGINAL SAMPLES AVAILABLE FOR INVESTIGATION OF THE LEAKAGE FROM PORT AS REPORTED BY THE CUSTOMER THE DEFECT CANNOT BE CONFIRMED. THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VENFLON¿ IV CANNULA LEAKED FROM THE INJECTION PORT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO VENFLON2 SKU 391451 LOT 0182212 HAVE BEEN REMOVED FROM PATIENT DURING TO LEAKAGE FROM INJECTION PORT. THE LEAKAGE HAS BEEN FOUND AFTER INSERTION AND LEAKAGE HAS CONTINUED EVEN WITH PORT CLOSED WITH PRE-ATTACHED CLOSING DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438248 BD VENFLON¿ IV CANNULA INTRAVASCULAR CATHETER FOZ 0182212

    Patients

    Seq Age Sex Outcome Treatment
    1