MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CUH C-SECTION PACK-LF

Catalog Number	DYNJ32253G
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "utsw is having major issues with the c- section drape leaking" and the "issue: leaking where pouch and clear incise area is.".
Additional Manufacturer Narrative
According to the facility, leaks were noted in the patient viewing window of the delivery drapes during intrapartum procedures; the leaks resulted in a break in sterility and required the use of an additional drape as a workaround, patients were unable to view the infant during delayed cord clamping, and additional sterile supplies were needed.A sample has been requested for evaluation, and the investigation notes state: "biohazard sample review pending." confirmation status was not provided in the record, and a root cause was not provided in the record.No medical intervention, serious injury, or follow-up care has been reported.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: CUH C-SECTION PACK-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50877382
• Report Number: 1417592-2026-49608
• Device Sequence Number: 10690835
• Product Code: OHM
• UDI-Device Identifier: 10195327066536
• UDI-Public: 10195327066536
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/23/2026

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: DYNJ32253G
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2025
• 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: 10/30/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (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