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

Catalog Number	MDT2168286
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the or towels have lint that has been coming off and finding it in their heparinized saline bowls and after they wipe their wires down.There is a concern that this can potentially cause harm to a patient while doing angio type procedures.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.
Event or Problem Description
It was reported that the or towels have lint that has been coming off and finding it in their heparinized saline bowls and after they wipe their wires down.There is a concern that this can potentially cause harm to a patient while doing angio type procedures.

• Brand Name: MEDLINE
• Common Device Name: TOWEL,OR,DSP,ST,BLUE,STD,6/PK,12PK/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50038090
• Report Number: 1417592-2026-07914
• Device Sequence Number: 15909014
• Product Code: FRL
• UDI-Device Identifier: 10080196282746
• UDI-Public: 10080196282746
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MDT2168286
• Device Lot Number: 50525120099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown