MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GOWN,SIRUS,POLYRNF,SETINSLV,XL,20/CS

Catalog Number	DYNJP2202S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there were "strikethrough" saturation incidents where blood permeated through the abdominal & sleeve areas and onto the staffs' scrubs, clothing and skin.".
Additional Manufacturer Narrative
It was reported by the customer, during "recovery of a donor" blood and bodily fluids "seeped through gown, their scrubs, and ultimately onto their skin," and the area of the gown that allowed for permeation were the "abdominal and sleeve areas"; the user required "serologies" which were "all negative" and the staff member is doing "well at this time." the samples were tested using the w.L.Gore elbow lean test, performed by putting synthetic blood onto the gown and pressing, and both sleeves and the abdominal area of the returned gown were tested.Medline was unable to duplicate the reported issue, and the issue is not confirmed with received samples.Based on the investigation results, no further actions are being taken at this time.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: GOWN,SIRUS,POLYRNF,SETINSLV,XL,20/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50531972
• Report Number: 1417592-2026-28999
• Device Sequence Number: 10069089
• Product Code: FYA
• UDI-Device Identifier: 40080196304746
• UDI-Public: 40080196304746
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K182172
• 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): 08/31/2026

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: DYNJP2202S
• Device Lot Number: 31123120058E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2024
• 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: 09/04/2024
• Initial Report FDA Received Date: 08/31/2026
• 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