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

Catalog Number	DYNDL1177C
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that these laceration trays have instruments that do not hold suture needles and when the needle holder is used to tie a suture it has flaws in it which break the suture.
Additional Manufacturer Narrative
The customer reported laceration trays have instruments that do not hold suture needles and when the needle holder is used to tie a suture it has flaws in it which break the suture.A sample was received for investigation; medline received one unopened kit, observed the needle holder in the tray, and found that upon unlatching the needle holder it was extremely difficult to separate from the hinge, and upon functional testing the screw hinge appeared stuck as the jaw tips were unable to open and close smoothly making it difficult to use and operate.The reported defective needle holder condition was confirmed by medline sample evaluation; the vendor used the sample to hold silk, nylon, and polypropylene threads along with the metal suture and reported the needle holder did not cut, snag, or damage the threads and did not have sharp edges or scissors like blades that would allow it to cut the suture.Based on the complaint details, the root cause was considered to be a supplier product issue relating to the component manufacturing process, and the complaint was provided to the component manufacturing facility for further evaluation with supplier quality monitoring 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: CUSTOM LACERATION TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50715686
• Report Number: 1417592-2026-35846
• Device Sequence Number: 10696312
• Product Code: MCY
• UDI-Device Identifier: 40884389035451
• UDI-Public: 40884389035451
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/07/2026

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: DYNDL1177C
• Device Lot Number: 23ABH852
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2023
• 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: 06/15/2023
• Initial Report FDA Received Date: 09/10/2026
• 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