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

Catalog Number	DYNJ0365888N
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the last few have had faulty gowns, they¿re porous and blood has seeped through them.".
Additional Manufacturer Narrative
The customer reported issues with some of the c section packs, stating the gowns were faulty, porous, and blood had seeped through them.No sample or photo was received for the investigation; finished good production records and finished good pack build were reviewed, and there were no line down situations, run without approvals, deviations, non-conformance reports, or build issues that likely contributed to the reported issue.The defect was not able to be confirmed because no samples or detailed pictures were received, and without a sample it is difficult to determine a true root cause.Based on the review of the details provided, medline was unable to confirm the complaint issue or that the product failed to meet specifications, and there was no reported death or serious injury associated with this event.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.

• Common Device Name: DBD-C-SECTION PACK-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50770957
• Report Number: 1417592-2026-40286
• Device Sequence Number: 9717060
• Product Code: OHM
• UDI-Device Identifier: 40195327045273
• UDI-Public: 40195327045273
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/10/2026

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: DYNJ0365888N
• Device Lot Number: 23FMJ424
• 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: 09/29/2023
• Initial Report FDA Received Date: 09/15/2026
• 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