BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ IV CANNULA

    MDR report key: 9213460 · Received October 21, 2019

    Report

    Report Number
    2243072-2019-02332
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    October 2, 2019
    Report Date
    October 30, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿TIP DAMAGE HAPPENED AND HARD TO PUSH IN TO VEIN WHILE INSERTING¿ WITH LOT NUMBER 9171587 REGARDING ITEM # 391592 THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. THE DHR WAS REVIEWED AND NO NCP OR QN WAS RAISED ON THIS LOT DURING MANUFACTURING AND PRODUCTION OF THE LOT NUMBER 9171587 UNTIL LOT RELEASE. THE RETENTION SAMPLES OF 9171587 WERE RETESTED FOR THE CATHETER BLUNT TIP VERIFICATION TEST ON LATEX SHEET DRUM TESTS AND INSTRON IN REFERENCE TO THE SOP NUMBER (B)(4) ASSEMBLED VENFLON & VENFLON I INSPECTION AND TESTING WHICH SHOWED NO EVIDENCE OF CANNULA TIP DAMAGE. TESTS PERFORMED ON FIVE RETENTIONS SAMPLES SHOWED THAT ALL THE CATHETER TIP BLUNT TESTS WERE WITHIN CONFORMANCE TO BD SPECS. THEREFORE THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED FOR FURTHER INVESTIGATIONS. 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. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON¿ IV CANNULA TIP WAS DAMAGED. THIS OCCURRED ON 50 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USAGE OF VENFLON I 20G,END USER NOTICED TIP DAMAGE HAPPENED AND HARD TO PUSH IN TO VEIN WHILE INSERTING.

    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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VENFLON¿ IV CANNULA TIP WAS DAMAGED. THIS OCCURRED ON 50 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USAGE OF VENFLON I 20G,END USER NOTICED TIP DAMAGE HAPPENED AND HARD TO PUSH IN TO VEIN WHILE INSERTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010764 BD VENFLON¿ IV CANNULA CATHETER FOZ BECTON DICKINSON 9171587

    Patients

    Seq Age Sex Outcome Treatment
    1 Other