MAUDE Adverse Event Report: MEDLINE EXCELSIOR; SYRINGE, 5ML SALINE IN 10ML

Model Number EM-3513575

Device Problem Contamination (1120)

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

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the saline solution was "brownish." to date, no syringe-specific problem/issue has been reported.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.A sample was returned for evaluation and a large rust particle was observed to be embedded in the syringe piston which was the cause of the discolored fluid.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the saline solution was "brownish.".

• Type of Device: SYRINGE, 5ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE EXCELSIOR; 1933 heck drive; neptune NJ 07753 4428
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18937363
• MDR Text Key: 338241806
• Report Number: 2027791-2024-00020
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: EM-3513575
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other