MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-DSC FESS

Catalog Number	DYNJ61366A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "incorrect number of gauze 4x4 xray rfd in dsc fess pack (9) in pack." the account reported receiving 9 out of 10 gauze in the dsc fess pack.A photo was received for the investigation and showed a single gauze, with no other pack contents visible; finished good production records and finished good pack build were reviewed, and the bill of materials confirms that a total of ten gauze is intended to be included in the pack.Based on the received photo, medline was unable to confirm the reported issue.This item is received pre-counted and banded from the component supplier, with no further processing performed during pack assembly; therefore, the root cause is likely related to an error in the component manufacturing process, and supplier quality 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.
Event or Problem Description
It was reported that "incorrect number of gauze 4x4 xray rfd in dsc fess pack (9) in pack.".

• Brand Name: MEDLINE
• Common Device Name: DBD-DSC FESS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50221913
• Report Number: 1417592-2026-15853
• Device Sequence Number: 17517025
• Product Code: LRO
• UDI-Device Identifier: 10195327592653
• UDI-Public: 10195327592653
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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): 08/12/2026

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: DYNJ61366A
• Device Lot Number: 24IBG920
• 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: 06/04/2025
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (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