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

Model Number EMZ10051240Z

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/15/2019

Event Type  malfunction  

Event Description

It was reported that the pre-filled syringe leaked and sprayed fluid.

Manufacturer Narrative

It was reported that the pre-filled syringe leaked and sprayed fluid.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.No photo or sample were provided for evaluation.Visual and functional testing was performed using retained samples from the reported lot and they were found to be within specification.The reported problem/issue was not confirmed and a root cause was unable to be determined.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.

• Type of Device: DBD-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: 18954340
• MDR Text Key: 338280211
• Report Number: 2027791-2024-00026
• 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: 03/20/2024

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: EMZ10051240Z
• Device Lot Number: 3134719
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other