MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE, LUER LOCK, STERILE, 5ML

Model Number	SYR105010Z
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that leakage occurred with the syringe.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 problems/issues.Three (3) boxes of unused product were returned for evaluation and fifteen (15) samples were randomly chosen for evaluation.Visual inspection revealed no manufacturing defects preventing the samples from working properly.Functional testing was performed by filling the samples with fluid and then emptying them.None of the samples leaked or cracked and the reported problem/issue was not confirmed.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 or Problem Description
It was reported that leakage occurred with the syringe.

• Common Device Name: SYRINGE, LUER LOCK, STERILE, 5ML
• 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: 18921844
• Report Number: 1417592-2024-00159
• Device Sequence Number: 20768055
• Product Code: FMF
• UDI-Device Identifier: 30080196310177
• UDI-Public: 30080196310177
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2024

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: SYR105010Z
• Device Lot Number: 180611
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown