MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-GENERAL LAPAROSCOPY KIT

Catalog Number	DYNJ904574D
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that xray gauze missing qr code on packaging that¿s needed for counting.Component picture on medpack shows qr code should be on packaging for customer to log in system.
Additional Manufacturer Narrative
The customer reported xray gauze missing the qr code and the reported issue was incorrect component.A photo and a sample were received, including one photo along with five bundles of gauze as the physical samples; finished good production records, finished good pack build, and trending were reviewed.Upon examination of the photo and physical sample, medline observed the incorrect component was received and the gauze provided did not contain the qr code, confirming the reported issue.Based on the complaint details, photos and physical sample this issue was caused by a manual picking error; production and qc managers have been notified of the reported issue, feedback will be provided to the build team for awareness and to prevent recurrence in the future, and the division will monitor this issue for trending purposes.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-GENERAL LAPAROSCOPY KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50797347
• Report Number: 1417592-2026-43172
• Device Sequence Number: 10529384
• Product Code: FDE
• UDI-Device Identifier: 10195327552305
• UDI-Public: 10195327552305
• 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): 09/16/2026

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: DYNJ904574D
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2025
• 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: 08/20/2025
• 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