MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY,CIRCUMCISION

Catalog Number	DYNJ04078
Medical Device Problem Codes	Product Quality Problem (1506); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the drape that comes in the tray is a foam drape that does not lay flat," "there is not a safety scalpel in the kit.It has a cap," and "the clamp that comes in the kit does not clamp correctly.".
Additional Manufacturer Narrative
The account reported that the drape does not lay flat, there is not a safety scalpel in the kit, and the clamp that comes in the kit does not clamp correctly.No sample or photo was provided; finished good production records, finished good pack build, account complaint history, and component complaint history were reviewed, with no line down situations, no issues with the build that likely contributed to the reported issue, and no similar reported issues in the past 6 months.With the information provided, medline was unable to confirm the reported issue and unable to confirm the root cause of the issue.Division to monitor 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: TRAY,CIRCUMCISION
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50889423
• Report Number: 1417592-2026-50518
• Device Sequence Number: 9826288
• Product Code: OHG
• UDI-Device Identifier: 40080196846673
• UDI-Public: 40080196846673
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: DYNJ04078
• Device Lot Number: 23KBW278
• Was Device Available for Evaluation?: Yes
• 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: 01/03/2024
• Initial Report FDA Received Date: 09/24/2026
• 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: Male