BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.9% SODIUM CHLORIDE I.V. FLUSH SYRINGE 10ML FILL IN A 12ML SYRINGE

    MDR report key: 15418393 · Received September 13, 2022

    Report

    Report Number
    MW5112001
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    September 10, 2022
    Report Date
    September 10, 2022
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    NGT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED A BOX OF 100 10ML SALINE FLUSHES NURSE ASSIST BRAND FROM EDGEPARK MEDICAL SUPPLY COMPANY. UPON ARRIVING THE FLUSHES COULD NOT BE USED BECAUSE WHEN I OPENED THE BOX FROM MANUFACTURER THE END OF THE INDIVIDUAL PLASTIC PACKAGING WAS NOT SEALED ON ONE END. I CALLED EDGEPARK AND GOT A REPLACEMENT THEY SEND ANOTHER BOX FROM THE SAME LOT AND AGAIN THEY WERE NOT USABLE. CALLED AND GOT A THIRD REPLACEMENT BOX WHICH ARRIVED TODAY. FOR THE REPLACEMENTS I WAS ASSURED THEY WOULD SEND A DIFFERENT LOT NUMBER AND PULL THE REMAINING BAD LOT HOWEVER IT'S CLEAR THEY DIDN'T BECAUSE AGAIN THE 3RD BOX WAS UNUSABLE. I CAN'T TRUST THAT THEY ARE SAFE TO USE WITH MY CENTRAL LINE FOR IV MEDICATIONS BECAUSE ONE END WAS NOT SEALED HOW IT SHOULD HAVE BEEN. I'VE LEFT MESSAGES, EMAILS, AND HAVE BEEN TOLD THE QUALITY CONTROL PERSON AT NURSE ASSIST WOULD GET IN TOUCH REGARDING THE PROBLEM. IT'S BEEN WEEKS AND I CAN'T GET A HOLD OF ANYONE. THIS LOT OF FLUSHES NEEDS TO BE TAKEN OFF THE SHELVES; IT IS NOT SEALED, THEREFORE NO SAFE FOR USE IN CENTRAL LINES OR OTHER IV LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2497339 0.9% SODIUM CHLORIDE I.V. FLUSH SYRINGE 10ML FILL IN A 12ML SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT NURSE ASSIST, LLC 22073576
    2497340 0.9% SODIUM CHLORIDE I.V. FLUSH SYRINGE 10ML FILL IN A 12ML SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT NURSE ASSIST, LLC 22073576
    2497341 0.9% SODIUM CHLORIDE I.V. FLUSH SYRINGE 10ML FILL IN A 12ML SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT NURSE ASSIST, LLC 22073576

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female TOO MANY TO LIST PLEASE CONTACT IF NEEDED