BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ASSEMBLY NAC-Y SITE

    MDR report key: 18314826 · Received December 12, 2023

    Report

    Report Number
    9616066-2023-02392
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    June 17, 2023
    Report Date
    January 26, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION BEING SUBMITTED FOR EXEMPT PRODUCT 8100-027 ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM IS ON THE CBI-095 ATTACHMENT I. PER CBI-095 ATTACHMENT I, THIS PRODUCT IS EXEMPT FROM US FDA REPORTING REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ASSEMBLY NAC-Y SITE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER FEEDBACK THERE ARE TWO LEAKAGE PRODUCTS ON THE NEEDLESS Y-SITE WAS DETECTED SURFACE ABNORMALITY FLOW LINES AND PITTING AS BELOW PHOTO. BD P/N 8100-027 (CUSTOMER P/N: (B)(6)). LOT NUMBER IS 20064566/20064565. **NOTE PRODUCT SHIPPED BACK IN 2020. CUSTOMER COMMENTS: BETCON DICKINSON FEEDBACK THAT THEIR SUPPLIER HAS CHANGED VALVE GATE PINS IN 2020, PLEASE CHECK : 1. THESE TWO LOTS WERE MANUFACTURED BEFORE OR AFTER IMPROVEMENT? 2. DOES SUPPLIER DO PREVENTIVE MAINTENANCE EVERY 3 MONTHS REGULARLY? CAN SHARE PREVENTIVE MAINTENANCE RECORDS AND REPLACEMENT OF PINS RECORDS OF 2023? MFGRG SITE: (B)(4). COMPLAINT NEEDS TO BE HANDLED BY THE MFGRG. SITE.

    Description of Event or Problem · 0

    MATERIAL: 8100-027, BATCH: 20064566. IT WAS REPORTED BY THE CUSTOMER THAT THERE ARE TWO NEEDLESS Y-SITES THAT ARE LEAKING AND DETECTED SURFACE ABNORMALITY FLOW LINES AND PITTING AS BELOW PHOTO. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER FEEDBACK THERE ARE TWO LEAKAGE PRODUCTS ON THE NEEDLESS Y-SITE WAS DETECTED SURFACE ABNORMALITY FLOW LINES AND PITTING AS BELOW PHOTO. BD P/N 8100-027 (CUSTOMER P/N: 300-0000391-00 ) LOT NUMBER IS 20064566/20064565. NOTE PRODUCT SHIPPED BACK IN 2020. CUSTOMER COMMENTS: BETCON DICKINSON FEEDBACK THAT THEIR SUPPLIER HAS CHANGED VALVE GATE PINS IN 2020, PLEASE CHECK : 1. THESE TWO LOTS WERE MANUFACTURED BEFORE OR AFTER IMPROVEMENT? 2. DOES SUPPLIER DO PREVENTIVE MAINTENANCE EVERY 3 MONTHS REGULARLY ? CAN SHARE. PREVENTIVE MAINTENANCE RECORDS AND REPLACEMENT OF PINS RECORDS OF 2023 ? MFGRG SITE: BD TJ MEXICO. COMPLAINT NEEDS TO BE HANDLED BY THE MFGRG. SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384050 BD ASSEMBLY NAC-Y SITE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 20064565

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown