MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LAPAROTOMY PACK

Catalog Number	DYNJ82680
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the towels coming in some of the packs have "towel lint" on them and "this particular towel with lint was found in the laparotomy pack.".
Additional Manufacturer Narrative
It was reported that "the towels coming in some of the packs have "towel lint" on them.I understand the lint is sterile, but we wouldn¿t want it accidentally getting into a patient.This particular towel with lint was found in the laparotomy pack and this concerns me because these are often used on open cases.I have attached pictures to help you understand what i mean towels are also used on total joint procedures, if lint remained in the joint it would most likely cause additional inflammation with potential for joint infection with increase procedural cost".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: DBD-LAPAROTOMY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: donovan frazier ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50223167
• Report Number: 1417592-2026-15965
• Device Sequence Number: 20207824
• Product Code: FDE
• UDI-Device Identifier: 40195327202829
• UDI-Public: 40195327202829
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/12/2026

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: DYNJ82680
• Device Lot Number: 23KMC687
• 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: 03/20/2024
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown