MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TOWEL,OR,DSP,ST,BLUE,DLX,6/PK,12PK/CS

Catalog Number	MDT2168206
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have a bad batch of sterile towels.They have a different quality than normal, and they have pieces of lint in them".
Additional Manufacturer Narrative
The customer reported a bad batch of sterile towels that had a different quality than normal and pieces of lint in them; according to the customer, the surgeon was hand drying before downing a surgical gown for a cataract implant when it was noticed that the sterile towels had lint on them, and nothing went inside the patient, there was no serious injury, and no impact to the patient or procedure.An unopened pack provided by the customer was opened and each towel was visually inspected; of the 6 towels reviewed, there was no evidence of linting, foreign particulates, or loose threads.Based on this, the reported complaint was unconfirmed, and the cause code description was not confirmed with received sample.Two years of complaint history for this product number was reviewed; 2 other complaints were reported for linting issues, though they were not from this vendor 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,BLUE,DLX,6/PK,12PK/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50789792
• Report Number: 1417592-2026-42289
• Device Sequence Number: 10515255
• Product Code: FRL
• UDI-Device Identifier: 40080196834069
• UDI-Public: 40080196834069
• 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: MDT2168206
• Device Lot Number: 6052312010
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2024
• 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: 03/21/2024
• Initial Report FDA Received Date: 09/16/2026
• 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