MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYR W/NDLE,HYPODERM,LL,25GX5/8", 3ML

Model Number SYR103253Z

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that medication leaked behind the syringe plunger.No serious injury or adverse impact to a patient or a user was originally 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.One (1) box of product in new condition was received for evaluation.Visual and functional testing of returned samples was unable to reproduce or confirm the reported problem/issue.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 medication leaked behind the syringe plunger.

• Type of Device: SYR W/NDLE,HYPODERM,LL,25GX5/8", 3ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 19016240
• MDR Text Key: 339211281
• Report Number: 1417592-2024-00325
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30080196449563
• UDI-Public: 30080196449563
• 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: 04/01/2024

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: SYR103253Z
• Device Lot Number: 180730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 04/01/2024
• 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