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

Catalog Number EMZE010001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Dyspnea (1816)

Event Date 09/22/2023

Event Type  Injury  

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.

Event 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.

• Type of Device: 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: 17986585
• MDR Text Key: 326289811
• Report Number: 2027791-2023-00002
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00363807100015
• UDI-Public: 00363807100015
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• 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
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other