BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GEM V/NV 20D 0.2 FLTR

    MDR report key: 15127322 · Received July 28, 2022

    Report

    Report Number
    2243072-2022-01014
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    June 27, 2022
    Report Date
    September 6, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    50885403463967
    PMA / PMN Number
    K931173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, (B)(4). DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER STATE: THE CUSTOMER'S STATE WAS DETERMINED TO BE (B)(6) BASED ON THE AREA CODE PORTION OF THE PROVIDED PHONE #. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED BY CUSTOMER THAT THE LIPID TUBING WAS ABLE TO BE PRIMED BUT WOULD NOT INFUSE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER AND MATERIAL NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD GEM V/NV 20D 0.2 FLTR EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A LIPID TUBING THAT WAS ABLE TO BE PRIMED BUT WOULD NOT INFUSE. D1: MEDICAL DEVICE BRAND NAME: BD GEM V/NV 20D 0.2 FLTR. D4: UDI # (B)(4). D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 05-AUG-2022 G.5. PMA / 510(K)#: K931173. INVESTIGATION SUMMARY: 2 USED SAMPLES (MODEL#2232-0007 ) WERE RETURNED FOR QUALITY INVESTIGATION BY THE CUSTOMER. IT WAS REPORTED BY CUSTOMER THAT THE LIPID TUBING WAS ABLE TO BE PRIMED BUT WOULD NOT INFUSE WAS NOT OBSERVED. PRIOR TO FUNCTIONAL TESTING THE SETS WERE VISUALLY EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS LOADED INTO AN ALARIS PUMP AND AN INFUSION RUN WITH A 1ML/HR RATE WAS STARTED. THE INFUSION WAS STOPPED AFTER APPROXIMATELY 17 HOURS. THERE WAS NO "OCCLUSION" PROMPT ON THE PUMP. THE CUSTOMER COMPLAINT COULD NOT BE REPLICATED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL # 2232-0007 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DEFINITIVELY DETERMINED BECAUSE THE ISSUE COULD NOT BE REPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INFUSION SET EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A LIPID TUBING THAT WAS ABLE TO BE PRIMED BUT WOULD NOT INFUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD GEM V/NV 20D 0.2 FLTR EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A LIPID TUBING THAT WAS ABLE TO BE PRIMED BUT WOULD NOT INFUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344116 BD GEM V/NV 20D 0.2 FLTR INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2232-0007 UNKNOWN 50885403463967

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown