BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS

    MDR report key: 17927667 · Received October 12, 2023

    Report

    Report Number
    2243072-2023-01842
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 22, 2023
    Report Date
    January 3, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    37613203012448
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE OF ITEM NUMBER 2420-0500 WAS SUBMITTED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF FLOW ISSUE - BACK FLOW WAS VERIFIED BY INVESTIGATION. VISUAL INSPECTION OF THE INFUSION SET WAS CONDUCTED TO DETERMINE IF THERE WERE ANY COMPONENTS DAMAGED OR IF THERE ARE ANY BREAKS OR CRACKS IN THE TUBING. THERE WERE NO INDICATIONS OF DAMAGE TO THE ENTIRE ASSEMBLY. THE PRIMARY INFUSION SET SAMPLE 2420-0500 WAS PRIMED WITH WATER. A SAMPLE SECONDARY SET WAS PRIMED WITH WATER COLORED WITH BLUE DYE. THE SECONDARY SET WAS THEN CONNECTED, AS INSTRUCTED, TO THE PRIMARY INFUSION SET. A SIMULATED INFUSION WAS CONDUCTED. AFTER, APPROXIMATELY 80 ML OF FLUID WAS DISPENSED, THE BLUE DYE COLORED WATER CAN BE SEEN TRAVELING BACK PAST THE CHECK VALVE IN THE PRIMARY INFUSION SET. THE LOT NUMBER FOR THE INFUSION SET WAS REPORTED AS "UNKNOWN." THE DEVICE HISTORY REPORTS ARE BASED ON POSSIBLE LOT NUMBERS FOUND WHEN SEARCHING THE SMARTSITE ID NUMBERS ON THE SAMPLE SUBMITTED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0500 LOT NUMBER 23073146 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 19JUL2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0500 LOT NUMBER 23073147 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 20JUL2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE CHECK VALVE WAS FORWARDED TO THE SUPPLIER FOR FURTHER INVESTIGATION. THE SUPPLIER CONDUCTED AN INVESTIGATION ON THE CHECK VALVE BUT WAS NOT ABLE TO REPLICATE THE FAILURE. THE ROOT CAUSE FOR THE FAILURE COULD NOT BE DETERMINED. IMPLEMENTATION OF 100% BACKFLOW VERIFICATION DURING THE ASSEMBLY PROCESS IS CONDUCTED ON THE BACKFLOW CHECK VALVE AND WILL CONTINUE TO ENSURE CONTROLS ARE IN PLACE TO MINIMIZE QUALITY ISSUES. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A 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 FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. THE REPORTED LOT NUMBER [234154, 231981307] WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #[2420-0500 ]. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: 2420-0500 BATCH #: UNKNOWN IT WAS REPORTED BY CUSTOMER THAT THE INFUSION ON SECONDARY LINE STARTED BACKING UP INTO THE PRIMARY BAG. VERBATIM: COMPLAINT RECEIVED VIA EMAIL. EMAIL(S) ATTACHED. WE WOULD LIKE TO REPORT A PRODUCT FAILURE REGARDING THE BD ALARIS PUMP INFUSION SET REF#2420-0500 (ADDITIONAL NUMBERS ON TUBING 234154, 231981307) INCIDENT DATE: 09/22/2023. INCIDENT LOCATION: XXX CONTACT AT LOCATION: XXX INCIDENT DETAILS:¿ PATIENT WAS RECEIVING VENOFER AND THE INFUSION ON SECONDARY LINE STARTED BACKING UP INTO THE PRIMARY BAG. THE CONCERN IS THERE IS BACKFLOW VALVE ON THE PRIMARY THAT SHOULD PREVENT THE MEDICATION FROM BACK FLOWING. SEE PICTURES BELOW. THE MEDICATION WAS ON A SECONDARY AND THE PRIMARY WAS DROPPED.¿ PRODUCT AVAILABLE FOR RETURN: YES RESPONSE RECEIVED (B)(6) 2023. - ARE YOU ABLE TO PROVIDE THE BATCH NUMBER FOR THE DEFECTIVE SET? THE ONLY NUMBERS I HAVE ARE OFF THE TUBING THAT I EMAILED YOU. WE GO THROUGH OVER 100 SECONDARY SETS IN A DAY, SO I AM UNSURE OF THE BATCH. - HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? PATIENT IS FINE. NURSE NOTICED ISSUE DUE TO THE COLOR OF MEDICATION INFUSING TO THE NORMAL SALINE IN PRIMARY. PATIENT TREATMENT TOOK LONGER AS A RESULT OF ISSUE. - DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? NOT IS THIS CIRCUMSTANCE. - DID THE EVENT CAUSE PERMANENT IMPAIRMENT OF A BODY FUNCTION? NO. - DID THE EVENT REQUIRE MEDICAL OR SURGICAL INTERVENTION? NO. - DID THE EVENT CAUSE PERMANENT DAMAGE OF A BODY STRUCTURE? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS THERE WAS BACKFLOW DURING INFUSION. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: WE WOULD LIKE TO REPORT A PRODUCT FAILURE REGARDING THE BD ALARIS PUMP INFUSION SET REF# (B)(4). INCIDENT DETAILS:¿ PATIENT WAS RECEIVING VENOFER AND THE INFUSION ON SECONDARY LINE STARTED BACKING UP INTO THE PRIMARY BAG. THE CONCERN IS THERE IS BACKFLOW VALVE ON THE PRIMARY THAT SHOULD PREVENT THE MEDICATION FROM BACK FLOWING. THE MEDICATION WAS ON A SECONDARY AND THE PRIMARY WAS DROPPED.¿ PRODUCT AVAILABLE FOR RETURN: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969206 BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN 37613203012448

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown