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 02/26/2019

Event Type  malfunction  

Event Description

It was reported that "medication is leaking around the plunger" during use of the syringe.

Manufacturer Narrative

It was reported that "medication is leaking around the plunger" during use of the syringe.No serious injury or adverse impact to 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.No photo or sample were provided for evaluation.The reported problem/issue was unable to be reproduced or 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 (b)(4) on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

• 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: 19009641
• MDR Text Key: 339009122
• Report Number: 1417592-2024-00312
• 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: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SYR103010Z
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other