BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS

    MDR report key: 20842124 · Received December 4, 2024

    Report

    Report Number
    20842124
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 15, 2024
    Report Date
    December 2, 2024
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN ALIQUOT OF RED BLOOD CELLS (RBC) WAS PULLED INTO A 60 ML SYRINGE FOR A PATIENT IN THE NEONATE INTENSIVE CARE UNIT (NICU). THE SYRINGE WAS PLACED IN A PLASTIC BAG AND IN A TUBE CARRIER WITH A LARGE PIECE OF FOAM TO PROTECT THE SYRINGE. WHEN IT ARRIVED IN THE NICU, THE TOP CAP OF THE SYRINGE HAD SHEARED OFF IN THE TUBE STATION, LEAKING BLOOD INTO THE TUBE CARRIER. THE SYRINGE WAS BROUGHT BACK TO THE LAB FOR EVALUATION AND DISCARDED. AFTER CAREFUL EXAMINATION, IT APPEARS THAT THE CAP SNAPPED OFF RIGHT AT THE COLLAR, THE INTERNAL THREADS OF THE CAP DID NOT BREAK DUE TO TWISTING THE CAP TOO HARD. THIS IS THE 60 ML SYRINGE FROM CODAN US CORPORATION, LOT NUMBER 72486. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, MARIAN MEDICAL INC (PER SITE REPORTER). VENDOR/MANUFACTURER HAS OFFERED TO REPLACE ALL PRODUCTS WITH THESE LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850000 WALRUS SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION BASN-60/150 72486

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown