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

Catalog Number	DYNJ43406D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the surgeon was wearing the gown and the blood soaked through the arm sleeve.".
Additional Manufacturer Narrative
The account reported finding blood soaked through gown; according to the facility, during a procedure a strike through occurred on the staff members arm, the skin was cleaned with hot water and some alcohol, and there was no impact to the patient or procedure.A photo was received for investigation; the photo shows a blood stain on the surgical gown, medline was unable to determine if the stain is on the outside or inside of the gown, production records showed no non-conformances, and there were no issues with the pack build.The reported strikethrough could not be confirmed from the photo, and the updated cause code was dc: traced to user with knowledge.The surgical gowns currently used for the pack are classified as aami pb70 barrier level 3 rated, the gown is designed to be fluid resistant, however with enough force it may allow strikethrough to occur, and based on these details, the item performed to specifications.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-EXTREMITY PACK-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50933854
• Report Number: 1417592-2026-53291
• Device Sequence Number: 21213815
• Product Code: OJH
• UDI-Device Identifier: 40193489949170
• UDI-Public: 40193489949170
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/29/2026

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: DYNJ43406D
• Device Lot Number: 23AB1696
• 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: 04/28/2023
• Initial Report FDA Received Date: 09/29/2026
• 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