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

Catalog Number	MDT2168054
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that dark particates were found on every towel.
Additional Manufacturer Narrative
The customer reported dark particulates showing on nearly every towel, causing stoppage of cases on cardiovascular cases, and almost resulted in 1 death due to breakdown of an emergent case of a patient that was in critical condition/heart failure; follow-up noted no patient was actually harmed and the procedure was completed after breakdown, re-setup and delay.A physical sample was received from the customer; the sample was inspected and multiple small pieces of dark debris could be seen on the towel.The reported issue was confirmed.Based on the vendor internal investigation, the debris present is from the winding process of the cotton where foreign fibers mix into the cotton that could not be removed after bleaching; two years of complaint history was reviewed for this product, no other complaints were reported for dark particulates regarding this product making this an isolated incident, 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,WHITE,DLX,4/PK,20PK/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50776992
• Report Number: 1417592-2026-41084
• Device Sequence Number: 21279841
• Product Code: FRL
• UDI-Device Identifier: 40080196743460
• UDI-Public: 40080196743460
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/11/2026

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: MDT2168054
• Device Lot Number: 84323100109
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2024
• 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: 05/08/2024
• Initial Report FDA Received Date: 09/15/2026
• 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): No
• Patient Sequence Number: 1
• Patient Sex: Unknown