BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Y SITE ASSEMBLY

    MDR report key: 17200202 · Received June 26, 2023

    Report

    Report Number
    9616066-2023-01256
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    June 2, 2023
    Report Date
    July 24, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    70885403463671
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A COMPLAINT OF THE INCORRECT MATERIAL BEING RECEIVED WAS REPORTED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW FOR MODEL: 8100-029, LOT NUMBER: 22028896 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WERE BUILT ON 11FEB2022. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A PREVIOUS INVESTIGATION FOR THIS DEFECT DETERMINED THE ROOT CAUSE TO BE A LACK OF RACKS IN THE PACKING AREA. SINCE THERE WAS A SINGLE RACK TO HAVE THE PROCESS MATERIAL AVAILABLE GENERATING THE RISK OF MIXING. DUE TO AN INCREASE IN INCIDENTS OF THIS FAILURE MODE, A TREND FOR THIS PACKAGING ISSUE HAS BEEN IDENTIFIED FOR THIS PRODUCT LINE, A CAPA (CORRECTIVE ACTION PREVENTATIVE ACTION) HAS BEEN INITIATED, AND A TEAM HAS BEEN ASSEMBLED IN ORDER TO INVESTIGATE THE ISSUE. THE FOLLOWING CORRECTIVE ACTIONS ARE IN PROCESS OF BEING IMPLEMENTED; ASSIGNING AN EXCLUSIVE RACK FOR THE STORAGE OF MATERIAL, REQUIREMENT TO PLACE MATERIAL IN THE WEIGHING AREA, ASSIGNING AN APPROPRIATE PLACE TO RACK THE MATERIAL TO BE WEIGHED AND SEALED, DEFINITION OF SHIFTS AND SCHEDULES FOR THE ACTIVITIES OF RETURN OF SURPLUS MATERIAL, AND AN EXCLUSIVE RACK WILL BE INCORPORATED FOR THE MATERIAL IN PROCESS. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD Y SITE ASSEMBLY THERE WAS A MIX OF PRODUCT TYPES IN A PACK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVING INSPECTION REPORTED THAT DURING QUALITY INSPECTION THAT BOXED LABELED PN 30-2956 (P/N 8100-029) WERE RECEIVED WITH INCORRECT MATERIAL INSIDE PN 31-1038 (P/N 8100-026) REFER TO PICTURES/PHOTOS PROVIDED IN THE ATTACHMENTS. 52,500 PCS ON HOLD/REQUESTING RETURN. REF CUSTOMER (B)(6) ON DOCUMENTATION. ADDITIONAL INFORMATION RECEIVED ON 6 JUNE BY BD SALES WANT TO BE CLEAR AND PROVIDE THE UPDATE TO THE COMPLAINT DESCRIPTION . AS CONFIRMED: ¿¿¿¿¿WE RECEIVED MIXED PRODUCT. IN THE BAGS THERE WERE FOUND TO BE TWO DIFFERENT SIZES. ¿.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477520 BD Y SITE ASSEMBLY INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22028896 70885403463671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown