BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR

    MDR report key: 17051870 · Received June 2, 2023

    Report

    Report Number
    2243072-2023-00942
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 10, 2023
    Report Date
    July 5, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403236600
    PMA / PMN Number
    K083472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD SEVERAL EXTENSION SETS THAT ARE LEAKING WHEN USING IN RADIOLOGY TO PUSH CONTRAST. WHEN THEY PUSH THE CONTRAST IT STARTS TO LEAK OUT ALL OVER THE PATIENT D1: MEDICAL DEVICE BRAND NAME: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR D2: MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D4: UDI #:(B)(4) D4: MEDICAL DEVICE CATALOG #: MP5301-C D4: MEDICAL DEVICE LOT #: 23029263 D4: MEDICAL DEVICE EXPIRATION DATE: 17-FEB-2026 H4: DEVICE MANUFACTURE DATE: 17-FEB-2023 G2: MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. G.5. PMA / 510(K)#: K083472 H6: INVESTIGATION SUMMARY NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF LEAKAGE WHEN PUSHING IN CONTRAST COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 23029263. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED WITHOUT A FAILURE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. 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 FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD SEVERAL EXTENSION SETS THAT ARE LEAKING WHEN USING IN RADIOLOGY TO PUSH CONTRAST. WHEN THEY PUSH THE CONTRAST IT STARTS TO LEAK OUT ALL OVER THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ INFUSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD SEVERAL EXTENSION SETS THAT ARE LEAKING WHEN USING IN RADIOLOGY TO PUSH CONTRAST. WHEN THEY PUSH THE CONTRAST IT STARTS TO LEAK OUT ALL OVER THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509295 BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MP5301-C 23029263 10885403236600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown