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	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that small towel fibers or lint appear to be sticking to surgical gloves during procedures.The concern is that these fibers may be entering the surgical site.
Additional Manufacturer Narrative
The customer reported that small towel fibers or lint appear to be sticking to surgical gloves during procedures, and during an "ep procedure" on (b)(6) 2025, "a lot of blue towel fibers" were observed on gloves and the wire.The provided photo was reviewed, the provided sample was evaluated, the vendor was notified of the issue, and trend analysis was performed by reviewing the past two years of complaint data.The or towels were noted to shed lint, confirming the reported issue, and the product failed to meet specifications.The vendor noted that the cause of the issue is from lack of the vacuuming the product after the seaming process, and as a corrective action, vacuuming equipment will be added into the folding process; no further investigation into the cause and complaint is warranted, and there has been no change to the reportability decision associated with this complaint.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,4/PK,20PK/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50803982
• Report Number: 1417592-2026-43582
• Device Sequence Number: 8900526
• Product Code: FRL
• UDI-Device Identifier: 20080196834058
• UDI-Public: 20080196834058
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/16/2026

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: 50525020030
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2025
• 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: 08/18/2025
• Initial Report FDA Received Date: 09/17/2026
• 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