BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 18255596 · Received December 4, 2023

    Report

    Report Number
    3002695476-2023-00007
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    February 23, 2023
    Report Date
    December 4, 2023
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    UDI-DI
    40884389338231
    PMA / PMN Number
    K083042
    Removal / Correction Number
    1650927-3OCT2023-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXTENDED TIME BETWEEN DATE OF EVENT AND DATE OF THIS REPORT IS DUE TO NURSE ASSIST RECENTLY RECLASSIFYING THIS TYPE OF OCCURRENCE AS HAVING THE POTENTIAL FOR CAUSING OR CONTRIBUTING TO A DEATH OR A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NURSE ASSIST IS CONDUCTING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS TO IDENTIFY ALL OCCURRENCES OF MALFUNCTION OF THE STERILE BARRIER.

    Description of Event or Problem · 0

    ON 23-FEB-2023, CUSTOMER NOTIFIED NURSE ASSIST VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM CUSTOMER: RECEIVED THIRTEEN (13) BOTTLES OF RDI30295. IT WAS STATED THEY WERE LEAKING. THERE WAS NO SHIPPING DAMAGE. SOME OF THE SAMPLES HAD EMPTY BOTTLES BUT THE SEAL SEEMED LOOSE AND WAS STARTING TO LIFT. OTHERS WERE PARTIALLY EMPTY WITH LOOSE SEALS AS WELL AND ONE WAS PARTIALLY EMPTY BUT LOOKED FULLY SEALED. THESE BOTTLES WERE REPORTED BY THE INITIAL REPORTER AS LEAKING PRIOR TO USE ON A PATIENT. THERE WAS NO REPORT OF ANY PATIENT IMAPCT OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450751 NURSE ASSIST, LLC USP STERILE WATER, SCREW TOP BOTTLE FRO NURSE ASSIST, LLC RDI30295 22063530 40884389338231

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown