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

Model Number	EMZE010001
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Chest Pain (1776); Nausea (1970); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that a patient experienced a "negative reaction.".

• Common Device Name: 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
• Report Number: 2027791-2024-00001
• Device Sequence Number: 12815169
• Product Code: NGT
• UDI-Device Identifier: 00363807100015
• UDI-Public: 00363807100015
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown