BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D LOW SORB 2SS 0.2M CV

    MDR report key: 18969009 · Received March 25, 2024

    Report

    Report Number
    9616066-2024-00458
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    February 28, 2024
    Report Date
    May 8, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    10885403232343
    PMA / PMN Number
    K022209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THERE WAS A LEAK. ONE PARTIAL SAMPLE MODEL 11532269, LOT 23115345 WAS RETURNED FOR INVESTIGATION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. THE ONLY PART OF THE SET THAT WAS RETURNED WAS THE TUBING AFTER THE MOST DISTAL SMARTSITE. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE CUSTOMER COMPLAINT WAS VERIFIED AND A QUALITY NOTIFICATION WAS SENT TO THE MANUFACTURER. FROM THE MANUFACTURER'S INVESTIGATION, THIS ISSUE COULD NOT BE REPLICATED IN THE PRODUCTION PROCESS AND NO OPPORTUNITIES WERE FOUND IN THE MANUFACTURING OF THE MODEL AND AFFECTED COMPONENT. THEREFORE, THE ROOT CAUSE IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW FOR MODEL 11532269 LOT NUMBER 23115345 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 28NOV2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Additional Manufacturer Narrative · 0

    (B)(4) : INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFO

    Description of Event or Problem · 0

    MATERIALS: 11532269 BATCH#: 23115345 IT WAS REPORTED BY THE CUSTOMER THAT LEAKING BLOOD AND CHEMO THANK YOU IN ADVANCE FOR YOUR FOLLOW-UP ON THIS PRODUCT CONCERN AILIN CHEN PURCHASING CLERK, CLINICAL SOURCING TEAM CLINICAL SUPPORT DEPARTMENT. : CHC COMPLAINT REFERENCE (B)(4) HOSPITAL COMPLAINT REFERENCE (B)(4) CUSTOMER (HOSPITAL) NAME: (B)(6) HEALTH CUSTOMER ADDRESS: (B)(6) CONTACT NAME: (B)(6) PHONE: (B)(6) E-MAIL: (B)(6) CORRESPONDENCE LANGUAGE: ENGLISH CAT# OF PRODUCT BEING COMPLAINED: AL11532269 DESCRIPTION OF PRODUCT: SET CHECK VALVE 0.2MIC 2NF 87/6IN 2PC MALE L/L 20EA/CA LOT OR S/N: (B)(6) COMPLAINT CATEGORY: LEAKING REPORTABLE: NO INCIDENT DATE: ON (B)(6) 2024 HOSPITAL COMPLAINT REFERENCE (B)(4). DETAILS OF COMPLAINT (REPORTED ISSUE): FROM: (B)(6) [PHSA] SENT: MONDAY, ON (B)(6) 2024 11:41 AMTO: GMB-CAN-CHC-COMPLAINTS CC: (B)(6) [VCH] ;(B)(6) [PHSA] ; DATA ENTRY SC DATA (B)(6) PLEASE FOLLOW UP WITH (B)(6) FOR THE PRODUCT CONCERN OUTLINED BELOW WITHIN 3 BUSINESS DAYS; AND ADVISE OF ANY SPECIAL SHIPPING INSTRUCTIONS FOR PICK UP, COURIER OR DISCARDING OF PRODUCT. PLEASE INVESTIGATE AND FOLLOW UP WITH A WRITTEN REPORT FROM YOUR QUALITY ASSURANCE AS TO YOUR FINDINGS AND RESOLUTIONS. PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: ON (B)(6) 2024 HOSPITAL: (B)(6) HOSPITAL : LEUKEMIA/BMT PRODUCT: BD ALARIS PUMP INFUSION SET 0.2 MICRON FILTER W/ BACK CHECK VALVE LOW SORBING VMID: 11532269 LOT NUMBER: (10)23115345 PRODUCT EXPIRY DATE: 21-NOV-2026 NUMBER OF DEFECTIVE PRODUCT(S): 1 IS SAMPLE AVAILABLE: YES CONCERN DESCRIPTION: SELF DISCONNECT - LEAKING BLOOD AND CHEMO THANK YOU IN ADVANCE FOR YOUR FOLLOW-UP ON THIS PRODUCT CONCERN AILIN CHEN PURCHASING CLERK, CLINICAL SOURCING TEAM CLINICAL SUPPORT DEPARTMENT SAMPLE AVAILABLE SUPPLIER PLEASE SEND CUSTOMER SAMPLE RETURN INSTRUCTIONS CUSTOMER INDICATED THAT THEY WISH TO BE PROVIDED WITH THE FINAL RESULTS OF THIS INVESTIGATION.** COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: 1ST TIME CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS HEALTH CANADA BEEN INFORMED? NO QTY AFFECTED: (B)(4) EA SAMPLES AVAILABLE? YES IS CUSTOMER REQUESTING AN RGA?: NO RETURN QTY: QTY SAMPLES: (B)(4) EA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441808 AS LVP 20D LOW SORB 2SS 0.2M CV INTRAVENOUS EXTENSION TUBING SET FPA BECTON DICKINSON 23115345 10885403232343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown