MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP SYRINGE, LUER LOCK, STERILE, 20ML; Syringe, piston

Model Number SYR120010

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that leakage around the syringe plunger was noted.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.Four (4) used samples were returned for evaluation and fluid was noted to be in the middle of the rubber stopper.The reported problem/issue was confirmed and it was determined to be caused by a defective plunger that allowed fluids to come between the rubber seal and the plunger.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 leakage around the syringe plunger was noted.

• Brand Name: SYRINGE, LUER LOCK, STERILE, 20ML
• Type of Device: Syringe, piston
• 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: 18975567
• MDR Text Key: 338682901
• Report Number: 1417592-2024-00226
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 40080196310228
• UDI-Public: 40080196310228
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SYR120010
• Device Lot Number: 180615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Date Manufacturer Received: 04/03/2019
• 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