MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GOWN,SIRUS,POLYRNF,BRTHSLV,L,1EA

Catalog Number	DYNJP2207SH
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "strike through of blood and fluids for long duration cases.".
Additional Manufacturer Narrative
According to the customer, on several occasions including 7/14/2025, strikethrough of blood and fluids during long surgical cases occurred; gowns and scrubs were changed following the strikethroughs, the personnel are "doing fine," and there was no serious injury, medical intervention, or follow-up care related to the reported incident.The customer was contacted and requested to provide additional information, and analysis of complaint data was performed over the past two years by all versions of the product and defect; it was determined that there are seven additional complaints with two related complaints from this customer with similar issues, therefore, there is no trend.Based on the results of the investigation and the lack of lot number information, medline was unable to confirm the complaint issue or that the product failed to meet specifications; the cause was documented as "sample required to determine cause." in the event additional information becomes available this complaint will be reopened, updated, and investigated as necessary, and 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,BRTHSLV,L,1EA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50820077
• Report Number: 1417592-2026-44860
• Device Sequence Number: 10157820
• Product Code: FYA
• UDI-Device Identifier: 10884389103227
• UDI-Public: 10884389103227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964142
• 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): 09/17/2026

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: DYNJP2207SH
• 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: 07/16/2025
• Initial Report FDA Received Date: 09/18/2026
• 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