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

Catalog Number	DYNDA2799
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that scissors broke during procedure.Sterile scissors collapsed in the middle of the circumcision's.
Additional Manufacturer Narrative
The customer reported that the scissors from the tray broke during the circumcision on 08/06/2025; no injury occurred, an alternate device was used, and no serious injury, medical intervention, or follow-up care was reported.Medline reviewed finished good production records, the finished good pack build, account complaint history, and component trending; no sample or photo was received for the investigation.At this time, medline was unable to confirm the reported defect, as no physical sample or detailed photographic evidence was provided; cause was unconfirmed and sample required to determine cause.The division will monitor this issue for trending purposes, and if a sample, photo, and/or additional information becomes available, this complaint will be reopened to be further investigated.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: CIRCUMCISION PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50668186
• Report Number: 1417592-2026-33597
• Device Sequence Number: 9228415
• Product Code: OHG
• UDI-Device Identifier: 10193489441956
• UDI-Public: 10193489441956
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/03/2026

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: DYNDA2799
• Device Lot Number: 25BBL517
• 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: 09/09/2025
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (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