BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SPECIALTY LOW-PRESSURE EXTENSION SET

    MDR report key: 17484371 · Received August 8, 2023

    Report

    Report Number
    9616066-2023-01694
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 20, 2023
    Report Date
    January 19, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403237560
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 1 USED AND 1 UNUSED SAMPLE WERE RECEIVED AND TESTED BY OUR QUALITY TEAM. THE USED SAMPLE WAS CLEARLY SEPARATED ABOVE THE NEEDLESS CONNECTOR Y-SITE (VERIFYING COMPLAINT). MICROSCOPE ANALYSES WAS USED AND THERE WAS A LACK OF SOLVENT (GLUE) ON TUBING WHERE IT WAS INSERTED INTO THE CONNECTOR. THE UNUSED SET HAD NO ISSUE AFTER BEING PULL TESTED AND INFUSED. THE MANUFACTURER WAS FORWARDED THE INFORMATION AND CONCLUDED THAT THE ROOT CAUSE WAS DUE TO IMPROPER INSERTION BY OPERATOR DURING THE ASSEMBLY OF SET. UNUSED SET BATCH NUMBER WAS USED FOR THE DEVICE HISTORY RECORD REVIEW: A DEVICE HISTORY RECORD REVIEW FOR MODEL MX5302 LOT NUMBER 22119180 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 14,403 UNITS IN 1 LOT NUMBER WAS BUILT ON (B)(6) 2022. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE BUILD OF THIS SET. LOT OF AFFECTED SET UNKNOWN

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: LOT WAS REPORTED; HOWEVER, THIS IS NOT A LOT #2211980 MANUFACTURED FOR THE REPORTED CATALOG #. D.4 DEVICE EXPIRATION DATE: UNKNOWN. H3. 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 · 0

    NO ADDTIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SPECIALTY LOW-PRESSURE EXTENSION SETS EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: Y SITE CONNECTION BECAME DISCONNECTED WHILE ATTACHED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507682 BD SPECIALTY LOW-PRESSURE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN 10885403237560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown