BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON I 22GA 0.8 MM X 25MM

    MDR report key: 12277862 · Received August 4, 2021

    Report

    Report Number
    2243072-2021-02020
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 6, 2021
    Report Date
    July 29, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 ¿TEAR FROM TIP OF I V CANNULA AND PATIENT FELT SEVERE PAIN¿ WITH LOT NUMBER 9171588 REGARDING ITEM # 391591, SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE DHR OF MATERIAL NUMBER 391591 AND LOT NUMBER 9171588 WAS CHECKED FOR ANY QUALITY NOTIFICATIONS, AND THERE WERE NO QUALITY NOTIFICATIONS RAISED ON THIS LOT. NO SAMPLES AND NO PHOTOGRAPHS RECEIVED FROM THE CUSTOMER AND WERE USED FOR INVESTIGATION OF THE REPORTED DEFECT. THE INVESTIGATING TEAM HAS USED TEN RETENTION SAMPLES OF MATERIAL CODE 391591 AND LOT NUMBER 9171588 FOR INVESTIGATING THE REPORTED DEFECT. NO RETENTION SAMPLE SHOWED ANY DAMAGE OR BLUNT CATHETER. THE COMPLAINT COULD NOT BE CONFIRMED. THE COMPLAINT IS RELATED TO PENETRATION ISSUE WHICH MAY OCCUR DUE TO BLUNT CANNULA OR CATHETER TIP DAMAGE. LINE ASSOCIATES AND QUALITY ASSOCIATES ARE DOING IPQC TO CAPTURE THIS DEFECT FROM THE LINE. TEAM IS DOING TESTING AFTER EVERY SET UP ON CANNULA ASSEMBLY STATION. AS MENTIONED ABOVE MANUAL CONTROL IS THERE SO AWARENESS TRAINING ABOUT THE COMPLAINT AND A SENSITIZATION PROGRAM ON THE IMPACT OF IPQC WAS PROVIDED TO LINE ASSOCIATES INCLUDING REFRESHER TRAINING ON Q-PS-19. REV40. ¿ASSEMBLED VENFLON, VENFLON I INSPECTION AND TESTING¿. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. RATIONALE: 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 VENFLON I 22GA 0.8 MM X 25MM CATHETER WAS DAMAGED. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INSERTION OF CATHETER VENFLON I IT TEAR FROM TIP OF IV CANNULA AND PATIENT FEEL SEVERE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173676 VENFLON I 22GA 0.8 MM X 25MM CATHETER FOZ 9171588

    Patients

    Seq Age Sex Outcome Treatment
    1