MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; EPIDURAL TRAY

Catalog Number	PAIN0412D
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "a foreign object floating around a syringe with medication.The black object appears to have come from the rubber plunger or perhaps drawn up from one of the medication vials".
Additional Manufacturer Narrative
The account reported a safety concerning a foreign object floating around a syringe with medication, and the black object appeared to have come from the rubber plunger or perhaps drawn up from one of the medication vials.A sample was received for investigation; the sample was one 6ml syringe not in its original packaging, in used condition, with chalky white residue inside the barrel and a dark spot to the right of the 1ml hash mark that appeared to be a smudge and did not appear to be particulate.The reported problem was confirmed as a marking/smudge within the barrel of the syringe.Due to the marking/smudge within the barrel of the syringe, the root cause is considered to be a vendor product issue relating to the component manufacturing process, and the complaint was provided to the component manufacturing facility for further evaluation while the quality team will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: EPIDURAL TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50932995
• Report Number: 1417592-2026-53151
• Device Sequence Number: 15852446
• Product Code: OFT
• UDI-Device Identifier: 40195327174416
• UDI-Public: 40195327174416
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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 Catalogue Number: PAIN0412D
• Device Lot Number: 23CMC345
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown