MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE EPIDURAL TRAY

Catalog Number	PAIN0620D
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on (b)(6) 2025 that there was "contaminant" identified "within the grooves of the plunger inside the syringe".The customer reported there was no patient or procedural involvement.The customer reported the procedure was completed utilizing a new pack.No additional details are available related to the customer reported issue.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.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 for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that on (b)(6) 2025 that there was "contaminant" identified "within the grooves of the plunger inside the syringe".
Additional Manufacturer Narrative
Update to h6: adverse event problem, investigation findings (c).

• Common Device Name: SYRINGE EPIDURAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22206470
• Report Number: 1417592-2025-00293
• Device Sequence Number: 17864252
• Product Code: OFT
• UDI-Device Identifier: 10195327148782
• UDI-Public: 10195327148782
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: PAIN0620D
• Device Lot Number: 24LBE281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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