MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE, LUER LOCK, STERILE, 3ML

Model Number SYR103010Z

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that "fluid is pushing backward thru the stopper" of the syringe plunger.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.Four (4) boxes of product in used condition was returned for evaluation.Visual and functional testing was unable to reproduce or confirm the reported problem/issue.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.Additional product lot reported = 180820, 180920.

Event Description

It was reported that "fluid is pushing backward thru the stopper" of the syringe plunger.

• Type of Device: SYRINGE, LUER LOCK, STERILE, 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: 19001454
• MDR Text Key: 338936211
• Report Number: 1417592-2024-00239
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30080196310160
• UDI-Public: 30080196310160
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SYR103010Z
• Device Lot Number: 180620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Date Manufacturer Received: 05/30/2019
• 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