BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON 2 PNK 20GA IV CANNULA

    MDR report key: 12465401 · Received September 13, 2021

    Report

    Report Number
    2243072-2021-02305
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 16, 2021
    Report Date
    September 7, 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: THE PHOTO WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF A VENFLON I 22GA FROM LOT # 1131930 REGARDING ITEM # 391592 WITH THE REPORTED ISSUE THAT ¿WHILE INSERTION OF IV CATHETER STYLET STUCK IN IV CANNULA WHILE TAKING IT OUT - RESULTANT TIP DAMAGE AND CROSS PUNCTURE¿. THE DHR WAS REVIEWED OF THE MATERIAL NUMBER 391592 AND LOT NUMBER 1131930 AND THERE WERE NO QUALITY NOTIFICATIONS REPORTED ON THIS LOT NUMBER FROM ITS PRODUCTION TO DISPATCH. NO SAMPLES AND ONE PHOTOGRAPH WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. THE RETENTION SAMPLES OF MATERIAL NUMBER 391592 AND LOT NUMBER IS 1131930 WERE USED FOR INVESTIGATION OF THE REPORTED DEFECT. THE RETENTION SAMPLES OF MATERIAL NUMBER 391592 AND THE LOT NUMBER 1131930 WERE ALSO USED FOR INVESTIGATION OF THE REPORTED DEFECT. OF THE TEN PIECES OF THE RETENTION SAMPLES THAT WERE USED FOR INVESTIGATION OF THE REPORTED DEFECT, NONE OF THE SAMPLES USED INDICATED THE REPORTED DEFECT. BD WAS UNABLE TO CONFIRM THE REPORTED DEFECT AS THERE IS NO ORIGINAL SAMPLE AND THE RETENTION SAMPLES DID NOT INDICATE THE REPORTED DEFECT IN ANY OF THE RETENTION¿S SAMPLES USED FOR SIMULATION OF THE DEFECT OF LEAKAGE. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. ROOT CAUSE DESCRIPTION: THE EXACT ROOT CAUSE COULD NOT BE CONFIRMED DUE TO UNAVAILABILITY OF THE SAMPLE. 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 2 PNK 20GA IV CANNULA NEEDLE WENT THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE INSERTION OF IV CATHETER STYLET STUCK IN IV CANNULA WHILE TAKING IT OUT - RESULTANT TIP DAMAGE AND CROSS PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363191 VENFLON 2 PNK 20GA IV CANNULA CATHETER FOZ 1131930

    Patients

    Seq Age Sex Outcome Treatment
    1