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

Catalog Number	DYNJ44235G
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "cautery pencil is not cutting.Intermittently working".
Additional Manufacturer Narrative
The account reported finding defective cautery, and the account reported that the cautery was intermittently working.A sample was received for investigation; the account returned one used cautery pencil, the buttons clicked with no issues, there were no cracks or visible defects noted with the pencil, cord, or prongs, and finished good production records and finished good pack build were reviewed with no issues found that could have contributed to the reported issue.The vendor reviewed the provided sample, found no notable conditions during visual inspection, completed functional testing, and observed that the pencil functioned normally when activated in the generator.Medline and the vendor were unable to confirm the reported issue or determine a root cause; 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: PEDIATRIC LAP PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50234448
• Report Number: 1417592-2026-16562
• Device Sequence Number: 21401055
• Product Code: FDE
• UDI-Device Identifier: 10195327427375
• UDI-Public: 10195327427375
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 08/13/2026

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: DYNJ44235G
• Device Lot Number: 24HBJ850
• Was Device Available for Evaluation?: No
• 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: 01/24/2025
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (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