MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MAJOR HEAD AND NECK PACK

Catalog Number	DYNJ38985G
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿the bovie pad and bovie are in the internal ¿sterilized¿ contents¿.It was later reported that ¿it was actually the bovie pad and the individual gown that the staff said was tucked inside the back table cover rather than on top of the pack as usual¿.
Additional Manufacturer Narrative
The account reported finding the pack assembled incorrectly, and an update received from the account stated it was actually the bovie pad and the individual gown that the staff said was tucked inside the back table cover rather than on top of the pack as usual.A sample was received, the account provided two sample packs, both sample packs were reviewed, the finished good production records were reviewed, and the finished good pack build was reviewed.Based on the complaint details and sample review, the gown component and grounding pad component were found to be correctly placed within the pack; therefore, the reported incorrect assembly was not confirmed.The cause code was dc: traced to user with knowledge, and the 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: DBD-MAJOR HEAD AND NECK PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50804615
• Report Number: 1417592-2026-43706
• Device Sequence Number: 10549008
• Product Code: OGR
• UDI-Device Identifier: 40195327385683
• UDI-Public: 40195327385683
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/16/2026

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: DYNJ38985G
• Device Lot Number: 24ABQ232
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/18/2024
• 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: 07/15/2024
• Initial Report FDA Received Date: 09/17/2026
• 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