BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON 2 - 20G

    MDR report key: 11382284 · Received February 25, 2021

    Report

    Report Number
    2243072-2021-00610
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    January 30, 2021
    Report Date
    March 4, 2021
    Manufacturer
    BECTON DICKINSON
    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 · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 0211865. D4: MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4: DEVICE MANUFACTURE DATE: UNKNOWN. H6: INVESTIGATION SUMMARY: AS NO SAMPLE OR PHOTOGRAPH WAS RECEIVED THE INVESTIGATION BY BD FOR EVALUATION. A QUALITY ENGINEER REVIEWED THE RETENTION SAMPLES FROM BATCH NUMBER 0211865 OF THE MATERIAL CODE 391492 WITH THE REPORTED ISSUE OF MISSING COMPONENTS. WE INVESTIGATED THIS PRODUCT IS PRODUCED ON M/C VA32. THIS MACHINE HAS A ROBOT ARM WHICH FILLS UP THE CAVITY. THERE IS A SENSOR THAT DETECTS THE PRESENCE OF THE PRODUCT ON THE CONVEYOR BEFORE THE ROBOTIC ARM PICKS UP THE PRODUCT. IN CASE THE CONVEYOR HAS MISSED THE PRODUCT FOR ANY REASON WHATSOEVER, THE ROBOTIC ARM IS DIRECTED TO PAUSE AND IS SUBSEQUENTLY ASKED TO PICK THE NEXT PRODUCT IN-LINE, SO THAT EMPTY CAVITY IS ELIMINATED. THIS IS ONE OF CASE WHERE, WE SUSPECT, THAT THE SENSOR WAS EITHER BLOCKED (OR WAS INACTIVE) WHEN THIS PRODUCT WAS BEING PACKED. FOR CORRECTIVE ACTION WE WILL NOW RESET THE VISION SENSOR TO REJECT THE NEXT 5 PRODUCTS THAT ARE FOLLOWED AFTER CAPTURING THE EMPTY POUCH ALL GET REJECTED SO THAT NO EMPTY POUCH GOES AHEAD IN PACKAGING. THE DHR SHOWED THERE WAS NO REPORTED COMPLAINT OR QUALITY NOTIFICATION RAISED ON THE SAME. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON 2 - 20G WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE EMPTY PACKS OF LUER LOK 50CC AND VENFLON I AND ALSO A DAMAGED CANNULA OF VENFLON I WAS RECEIVED.

    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)(6) HAS BEEN LISTED AND THE (B)(6) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 0211865 & 0003877. THESE DO NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENFLON 2 - 20G WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE EMPTY PACKS OF LUER LOK 50CC AND VENFLON I AND ALSO A DAMAGED CANNULA OF VENFLON I WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277853 VENFLON 2 - 20G CATHETER FOZ BECTON DICKINSON 0211865

    Patients

    Seq Age Sex Outcome Treatment
    1