MAUDE Adverse Event Report: MEDLINE EXCELSIOR; SYRINGE, 10ML SALINE IN 10ML

Model Number EMZE010001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Nausea (1970); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that following flushing of a dialysis catheter, a patient experienced a "negative reaction" that was described as "shortness of breath chest pressure and nausea." according to the reporting facility, after identification of these symptoms, the patient refused supplemental oxygen and that "after a few minutes the issues resolved." no death, serious injury, medical intervention, follow-up care, or other adverse patient/health impact has been reported to the manufacturer.No sample was returned for evaluation and the reported problem/issue could not be confirmed through product testing, however, investigation showed product efficacy for the reported lot of product.A definitive root cause could not be determined at this time.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a patient experienced a "negative reaction.".

• Type of Device: SYRINGE, 10ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE EXCELSIOR; 1933 heck avenue; neptune NJ 07753 4428
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18659097
• MDR Text Key: 335296009
• Report Number: 2027791-2024-00001
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: EMZE010001
• Device Lot Number: 3142763
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other