MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MINOR PACK

Catalog Number	DYNJ84916F
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that component 119376 radiopaque strips are loosely woven in and falling apart and out of the sponge.
Additional Manufacturer Narrative
The account reported finding defective - blue strips detached, and the reported issue was that radiopaque strips were loosely woven in and falling apart and out of the sponge.A sample was received containing one pack of unbanded gauze; each sheet of gauze was inspected, finished good production records were reviewed, and finished good pack build was reviewed with no issues identified that would contribute to the reported concern.Per review of the sample provided, medline confirmed the reported issue: one sheet of gauze was found to be defective, with the blue radiopaque strips not woven into the material correctly, some areas randomly woven in, and other areas tangled in itself on top of the material.Since this component is not manipulated during the pack assembly process, the root cause is a vendor product issue relating to the component manufacturing process; a risk assessment was completed and the incident was found to be acceptable, and there has been no change to the reportability decision associated with this complaint.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-MINOR PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: arundathi nomula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50275170
• Report Number: 1417592-2026-17858
• Device Sequence Number: 13232432
• Product Code: OJF
• UDI-Device Identifier: 10198459370403
• UDI-Public: 10198459370403
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 08/17/2026

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: DYNJ84916F
• Device Lot Number: 26AMF862
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/18/2026
• 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: 03/03/2026
• Initial Report FDA Received Date: 08/17/2026
• 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