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

Catalog Number	DYNJ88900
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there were only 9 raytec sponges in the pack.There should be 10.".
Additional Manufacturer Narrative
The account reported finding miscount raytec, and the reported issue occurred in item dynj88900.No sample or photo received for our investigation.The packs production record was reviewed and there were no line down situations, deviations, run-without, or non-conformance reports that might have had an impact on this issue; per review of the bill of materials, one pack of component 105232 - gauze xr surgcnt 4x4 16ply was to be utilized within the pack, and the gauze comes pre-banded prior to placement within the pack with no further manipulation or alteration done during the production process.At this time, we are unable to confirm the reported defect, as no physical sample or detailed photographic evidence was provided to support the investigation; the division 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-LAPAROSCOPY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50773191
• Report Number: 1417592-2026-40540
• Device Sequence Number: 21261949
• Product Code: FDE
• UDI-Device Identifier: 10198459213601
• UDI-Public: 10198459213601
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/15/2026

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: DYNJ88900
• Device Lot Number: 25JBM022
• Was Device Available for Evaluation?: Yes
• 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: 01/20/2026
• Initial Report FDA Received Date: 09/15/2026
• 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