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

Catalog Number	DYNDL1865A
Medical Device Problem Codes	Product Quality Problem (1506); Failure to Align (2522); Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the hemostats are not clamping because of misalignment and the end of the other two are so sharp they could cut someone.".
Additional Manufacturer Narrative
The account reported that hemostats were not clamping because of misalignment, the end of the other two were so sharp they could cut someone, and a baby had a cut incurred during a procedure with concern that it came from the instrument itself.The investigation reviewed finished good production records, finished good pack build, and trending; a sample was received, and the account returned 3 hemostats for investigation, two from an opened pack and one from an unopened pack.Upon visual inspection of the hemostats, no misalignment or excessively sharp tips were noted, and each component was tested, opening and closing each one onto each clamp, with no functional defects noted.The reported issue was not confirmed with the samples received, no root cause was identified, and upon testing the 3 hemostats received had no functional defects and no visual defects were observed.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-CIRCUMCISION TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50543941
• Report Number: 1417592-2026-29321
• Device Sequence Number: 10311816
• Product Code: OHG
• UDI-Device Identifier: 40889942865711
• UDI-Public: 40889942865711
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/01/2026

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: DYNDL1865A
• Device Lot Number: 23FBK354
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/23/2023
• 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: 09/28/2023
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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