MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TOWEL,OR,DSP,ST,BLUE,DLX,XR,6/PK,12PK/CS

Catalog Number	MDT2168206XR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "disposable blue towels sluffing onto their equipment.".
Additional Manufacturer Narrative
The customer reported observing lint debris from their or towels during use, and the facility reported that blue lint was noted on the angiographic wire during a tavr procedure with no reports of linting into the surgical site and no reports of serious injury or medical intervention.The provided photos were reviewed, the vendor was notified of the issue and sent the photos, and trend analysis was performed by reviewing the past two years of complaint data.Based on the results of the investigation, medline confirmed the reported issue and that the product failed to meet specifications.The vendor noted that the cause of the linting issue was the inherent property of the raw material, recycled cotton, which has short fibers and naturally produces lint, and a review of the complaint information as well as the results of the investigation indicated no need for further action at this time.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,DLX,XR,6/PK,12PK/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: urmi parekh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915484
• Report Number: 1417592-2026-52009
• Device Sequence Number: 17485306
• Product Code: FRL
• UDI-Device Identifier: 10080196778584
• UDI-Public: 10080196778584
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/25/2026

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: MDT2168206XR
• Device Lot Number: 26024100018
• 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: 11/25/2025
• Initial Report FDA Received Date: 09/28/2026
• 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