MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SPECIAL PROCEDURE PK

Catalog Number	DYNJ63880A
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blue or towels leaving particulate in the saline solution.
Additional Manufacturer Narrative
The account reported finding linting towels.A photo and a sample were received for investigation; 4 unused folded towels were received, two or towels had linting and two did not, and finished good production records and finished good pack build were reviewed.The reported issue was confirmed, as the two or towels found linting had a chunk of towel lint on the inside of the or towels.Based on the complaint details the root cause is considered to be a vendor product issue relating to the component manufacturing process, and the vendor response stated the root cause may be related to the sewing process if the suction outlet on the equipment is blocked; preventive measures include cleaning the tuyere of the sewing machine and training operators to clean the equipment according to requirements.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: SPECIAL PROCEDURE PK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931693
• Report Number: 1417592-2026-52939
• Device Sequence Number: 13183851
• Product Code: OES
• UDI-Device Identifier: 40195327277070
• UDI-Public: 40195327277070
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/28/2026

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: DYNJ63880A
• Device Lot Number: 23EDA467
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2023
• 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: 07/06/2023
• 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