BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD ALARIS¿ INFUSION SET

    MDR report key: 16075407 · Received December 29, 2022

    Report

    Report Number
    2243072-2022-02250
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 12, 2022
    Report Date
    February 2, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403198913
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD SECONDARY ADMINISTRATION SET, WERE BLOCKED WHILE ATTEMPTING TO BACKFLOW THE IV LINES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE ALSO RECEIVED COMPLAINTS FROM NURSING THAT THE RECENT SETS ARE NOT ALLOWING THEM TO BACKFLOW IV LINES." D1: MEDICAL DEVICE BRAND NAME: BD SECONDARY ADMINISTRATION SET, D2: MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D4: UDI # (B)(4). D4: CATALOG #: 10013364T. D4: MEDICAL DEVICE LOT #: 22089188 . D4: MEDICAL DEVICE EXPIRATION DATE: 15-AUG-2025. H4: DEVICE MANUFACTURE DATE: 08-AUG-2022. G2: MANUFACTURING LOCATION: (B)(4). G.5. PMA / 510(K)#: K790582 . D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 24-JAN-2023 . H6: INVESTIGATION SUMMARY ONE UNUSED SAMPLE, AND ONE PHOTO OF THE PRODUCT PACKAGING, OF MATERIAL NUMBER 10013364T, WAS SUBMITTED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF FLOW ISSUES - BACK FLOW COULD NOT BE VERIFIED DURING THE INVESTIGATION. EVALUATION OF THE SECONDARY SET WAS CONDUCTED BY FIRST VISUALLY INSPECTING THE SET FOR DAMAGES OR DEFECTS. NO DAMAGES OR DEFECTS WERE VISIBLY NOTICEABLE. THE SET WAS THEN PRIMED AND CONNECTED TO A SAMPLE PRIMARY INFUSION LINE TO CONDUCT A SIMULATED INFUSION. DURING THE INFUSION THE SECONDARY SET WORKED AS INTEND WITH NO SIGNS OF LEAKAGE, AIR-IN-LINE OR OCCLUSION. THE TUBING WAS ALSO CHECK TO SEE IF IT WOULD SEPARATE AT EACH OF THE JOINT LOCATIONS. THE TUBING SET DID NOT SEPARATE AT ANY OF THE LOCATIONS. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10013364T LOT NUMBER 22089188 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A ROOT CAUSE WAS NOT ESTABLISHED BECAUSE THE REPORTED FAILURE COULD NOT BE REPLICATED.

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND 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 (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SECONDARY ADMINISTRATION SET, WERE BLOCKED WHILE ATTEMPTING TO BACKFLOW THE IV LINES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE ALSO RECEIVED COMPLAINTS FROM NURSING THAT THE RECENT SETS ARE NOT ALLOWING THEM TO BACKFLOW IV LINES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF UNSPECIFIED BD ALARIS¿ INFUSION SETS WERE BLOCKED WHILE ATTEMPTING TO BACKFLOW THE IV LINES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE ALSO RECEIVED COMPLAINTS FROM NURSING THAT THE RECENT SETS ARE NOT ALLOWING THEM TO BACKFLOW IV LINES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409684 UNSPECIFIED BD ALARIS¿ INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10013364T 22089188 50885403198913

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown