BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET

    MDR report key: 11891475 · Received May 26, 2021

    Report

    Report Number
    2243072-2021-01548
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 27, 2021
    Report Date
    June 9, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D2: MEDICAL DEVICE BRAND NAME: AS LVP 20D 3SS CV BV, D4: CATALOG #: 11522558, D4: LOT # : 20116054, D4: MEDICAL DEVICE EXPIRATION DATE: 2023-11-17, D4: UDI #: (B)(4), G.5. PMA / 510(K)#: K944320, AND H4: DEVICE MANUFACTURE DATE: 2020-11-09. H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED FOR INVESTIGATION BY THE CUSTOMER. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. SET WAS PRIMED WITH SALINE AND ALLOWED TO FREE FLOW. EACH CLAMP WAS ACTIVATED ONE AT A TIME. NO FLOW WAS OBSERVED WHEN THE CLAMPS WERE OCCLUDING THE TUBING. THE SET WAS PLACED IN AN ALARIS PUMP AND ALLOWED TO FLOW FOR 125 ML/HR FOR 1 HR. THE INFUSION RUN COMPLETED WITHOUT ANY ISSUES. THE CUSTOMER COMPLAINT THAT 10 ML OF INFUSION DID NOT GET INFUSED AND WAS STILL IN THE TUBING COULD NOT BE REPLICATED. THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE ISSUE COULD NOT BE REPLICATED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 11522558 LOT NUMBER 20116054 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 18NOV2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: UNKNOWN; BATCH/ LOT #: UNKNOWN. WE HAD ANOTHER TUBING PULL AIR YESTERDAY. 10 ML OF INFUSION DID NOT GET INFUSED BECAUSE IT WAS STILL IN THE TUBING PATIENT WAS INFUSING ARGININE.

    Additional Manufacturer Narrative · 1

    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, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: UNKNOWN BATCH/ LOT #: UNKNOWN. WE HAD ANOTHER TUBING PULL AIR YESTERDAY. 10 ML OF INFUSION DID NOT GET INFUSED BECAUSE IT WAS STILL IN THE TUBING PATIENT WAS INFUSING ARGININE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786459 UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 20116054

    Patients

    Seq Age Sex Outcome Treatment
    1