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

Catalog Number	DYNJ03108LF
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "as soon as the provider tried to suture with the forceps the suture needle kept falling out." it was also reported that "it looks like a crack going through" and "when they close the ratchet the jaws do not always close completely.".
Additional Manufacturer Narrative
The customer reported that during patient use, the provider tried to suture with the forceps and the suture needle kept falling out; the customer also reported that it looked like a crack going through and that when providers close the ratchet the jaws do not always close completely.A photo and a sample were received for investigation, the sample was evaluated, finished good production records were reviewed, and the finished good pack build was reviewed.One of the needle holders received was observed to have a crack in the jaw, confirming the reported issue.Because medline does not alter the component before placing it in the kit, the root cause was determined to be a vendor/supplier product issue relating to the component manufacturing process; the complaint was provided to the component manufacturing facility for further evaluation and the supplier quality team 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: LACERATION TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50778307
• Report Number: 1417592-2026-41316
• Device Sequence Number: 9762138
• Product Code: MCY
• UDI-Device Identifier: 10080196841202
• UDI-Public: 10080196841202
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/14/2026

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: DYNJ03108LF
• Device Lot Number: 24LBU320
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2025
• 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: 04/17/2025
• Initial Report FDA Received Date: 09/15/2026
• 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