MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TOWEL,OR,DSP,ST,BLUE,STD,4/PK,20PK/CS

Catalog Number	MDT2168284
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that clinical staff were using towels in the or and surgeons notice that the patients were covered in lint from the towels.These are supposed to be the low lint towels, and having this happen creates a possible contaminatino issue.
Additional Manufacturer Narrative
The customer reported that clinical staff were using towels in the or and surgeons noticed that the patients were covered in lint from the towels, and the complaint was updated that lint was all over patients.At this time, a sample was not received for this complaint; without a physical sample or picture, this limits the ability to investigate the issue thoroughly and establish a root cause, and the product particulate criteria related to loose threads or attached threads had no failures based on a sample size of 200.The complaint history was reviewed for this product and identified 5 complaints reporting lint issues with the product, with no trend in the lots reported and 3 unconfirmed based on received samples; due to this, the complaint was not confirmed.The cause was listed as sample required to determine cause, and the divisional quality representative will continue to monitor this issue for tracking and trending purposes during quarterly trending.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: TOWEL,OR,DSP,ST,BLUE,STD,4/PK,20PK/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50947370
• Report Number: 1417592-2026-54433
• Device Sequence Number: 10429592
• Product Code: FRL
• UDI-Device Identifier: 40080196282730
• UDI-Public: 40080196282730
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/29/2026

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: MDT2168284
• Device Lot Number: 6052308014
• 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: 02/12/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown