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

Catalog Number	MDT2168284
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there appears to be lint on towel.".
Additional Manufacturer Narrative
A complaint was received related to lint debris found on or towels; the complaint information stated the issue did not occur during use and no injury occurred.The provided photo was reviewed, the vendor was notified of the issue and sent the provided photo, and trend analysis was performed by reviewing the past two years of complaint data; the photo showed the item in opened but unused condition with a foreign object resembling an accumulation of lint debris on the or towel.Based on the results of the investigation, medline was able to confirm the reported issue and that the product failed to meet specifications.The vendor noted that the root cause was lint contamination on or towels that originated during the folding process when accumulated raw material dust formed into lint on the folding machine belt, was not detected during cleaning, and was pressed onto the product, compounded by insufficient visual inspection by operators; the complaint investigation objective has been met and no further investigation into the cause and complaint is warranted, and an objectionable trend has not been identified.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 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50793505
• Report Number: 1417592-2026-42796
• Device Sequence Number: 18495712
• Product Code: FRL
• UDI-Device Identifier: 10080196282739
• UDI-Public: 10080196282739
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/15/2026

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: 6052503002
• 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: 10/24/2025
• Initial Report FDA Received Date: 09/16/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown