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

Catalog Number	EMZE010001
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility the patient was given "2l of oxygen nasal cannula" after "both lumens were flushed with the pre-filled syringe to keep catheter patent" and patient complained of being short of breath and their chest being heavy.
Additional Manufacturer Narrative
According to the facility the patient was given "2l of oxygen nasal cannula" after "both lumens were flushed with the pre-filled syringe to keep catheter patent" and patient complained of being short of breath and their chest being heavy.Per the facility nothing was infusing prior to the flush and after "5-7 minutes" the patient was discharged as stable.Per the facility no serious injury occurred.The sample was requested for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: SYRINGE, 10ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE EXCELSIOR; 1933 heck avenue; neptune NJ 07753
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17986345
• Report Number: 2027791-2023-00001
• Device Sequence Number: 7531209
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2023

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 Catalogue Number: EMZE010001
• Device Lot Number: 3142763
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown