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

Model Number	SYR105010
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that foreign particulate was noted within 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 problem/issue.Two (2) samples were returned for evaluation and the reported problem/issue was confirmed with hair noted within the samples.The samples were in used condition with packaging opened.A root cause was unable to be determined as due to the condition of the samples, it could not be confirmed whether or not the hair was already inside of the syringe barrel upon receiving the unopened product or if it occurred while the sample was in use.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.
Event or Problem Description
It was reported that foreign particulate was noted within 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: 18966556
• Report Number: 1417592-2024-00209
• Device Sequence Number: 20386779
• Product Code: FMF
• UDI-Device Identifier: 40080196310174
• UDI-Public: 40080196310174
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 03/24/2024

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: SYR105010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/24/2024
• 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