MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LAPAROSCOPY ABDOM PACK 171

Catalog Number	DYNJ84146
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there was gross strike thru with the medline level 3 gown during a procedure.Bilateral arms and abdomen of the wearer were contaminated.".
Additional Manufacturer Narrative
The customer reported gross strike thru with the medline level 3 gown during a procedure, and bilateral arms and abdomen of the wearer were contaminated.No sample or photo was received for the investigation; finished good production records, finished good pack build, account complaint history, and component complaint history were reviewed, with no line down situations, run without approvals, deviations, non-conformance reports, build issues, or similar reported issues in the past 6 months identified.The reported problem could not be evaluated with a sample or photo, and based on the review the item performed to specifications.The surgical gowns currently used for the pack are classified as aami pb70 barrier level 3 rated and are designed to be fluid resistant; however, with enough force they may allow strikethrough to occur, and the cause was documented as traced to user knowledge.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 ABDOM PACK 171
• 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: 50804603
• Report Number: 1417592-2026-43702
• Device Sequence Number: 16089217
• Product Code: FDE
• UDI-Device Identifier: 40195327337088
• UDI-Public: 40195327337088
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: DYNJ84146
• Device Lot Number: 23DMF637
• 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: 01/26/2024
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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