MAUDE Adverse Event Report: NURSE ASSIST, LLC 0.9% SODIUM CHLORIDE I.V. FLUSH SYRINGE 10ML FILL IN A 12ML SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Lot Number 22073576

Device Problems Unsealed Device Packaging (1444); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2022

Event Type  malfunction  

Event Description

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.

• Brand Name: 0.9% SODIUM CHLORIDE I.V. FLUSH SYRINGE 10ML FILL IN A 12ML SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC
• MDR Report Key: 15418393
• MDR Text Key: 299953477
• Report Number: MW5112001
• Device Sequence Number: 2
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/10/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 22073576
• Patient Sequence Number: 1
• Treatment: TOO MANY TO LIST PLEASE CONTACT IF NEEDED
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White