MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TOWEL,OR,DSP,ST,BLUE,DLX,10/PK,8PK/CS

Catalog Number	MDT2168210
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "debris in or towels.".
Additional Manufacturer Narrative
The customer reported debris in or towels, and photos were provided by the customer.The first photo depicts the labelling of the product and the second photo depicts the side of the stack which had the reported debris visibly there; inspection records were reviewed and showed that the product from this lot passed inspection and did not need re-inspection.The reported issue was confirmed based on the photograph provided by the customer.Upon further review of the photo, it appears to be a large piece of lint that can come from the machines during the production of the product, 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,DLX,10/PK,8PK/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50759278
• Report Number: 1417592-2026-39758
• Device Sequence Number: 9203378
• Product Code: FRL
• UDI-Device Identifier: 40080196743446
• UDI-Public: 40080196743446
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/14/2026

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: MDT2168210
• Device Lot Number: 84323070095
• Was Device Available for Evaluation?: No
• 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: 12/15/2023
• Initial Report FDA Received Date: 09/14/2026
• 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