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

Catalog Number	MDT2168204
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a couple packs of sterile towels had pieces of lint inside them and that the or staff was concerned about their safety; there was no reported death, serious injury, or medical intervention associated with this event.The provided photo was reviewed, the provided samples were evaluated, the vendor was notified of the issue, and trend analysis was performed by reviewing the past two years of complaint data.The photo and visual inspection of the or towels noted an accumulation of lint debris on the surface of the folded or towels, confirming the reported issue, and the product failed to meet specifications.Based on the vendor's internal investigation, lint formed from accumulated cotton dust during the folding process, settled into the folding machine's belt gaps, was compressed during operation, and cross-contaminated the product; no further investigation into the cause and complaint is warranted.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.
Event or Problem Description
It was reported that "we have had a couple packs of sterile towels have pieces of lint inside them.".

• Brand Name: MEDLINE
• Common Device Name: TOWEL,OR,DSP,ST,BLUE,DLX,4/PK,20PK/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899955
• Report Number: 1417592-2026-51214
• Device Sequence Number: 20291021
• Product Code: FRL
• UDI-Device Identifier: 20080196834058
• UDI-Public: 20080196834058
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: MDT2168204
• Device Lot Number: 50525060030
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/18/2025
• 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: 12/10/2025
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown