MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-BSMI CSECTION BIRTHING PACK

Catalog Number	DYNJ54946G
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drape had holes in it and was leaking.
Additional Manufacturer Narrative
The end user stated the drape had holes in it and was leaking, and the drape was not saved as they were unaware it had holes in it until it started leaking fluids from the c-section.No sample or photo was received for the investigation; finished good production records were reviewed and no non-conformances were noted, finished good pack build was reviewed and there were no issues, and trending found 0 additional reported complaints for this issue for the account and component in the past 6 months.Medline was not able to confirm the defect as there were no samples or detailed pictures received, and without a sample it is difficult to determine a true root cause for the reported issue.The supplier quality team will monitor this issue for trending purposes.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-BSMI CSECTION BIRTHING PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50776853
• Report Number: 1417592-2026-41055
• Device Sequence Number: 10754245
• Product Code: OHM
• UDI-Device Identifier: 40195327135455
• UDI-Public: 40195327135455
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/11/2026

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: DYNJ54946G
• Device Lot Number: 23EBI055
• Was Device Available for Evaluation?: No
• 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: 08/09/2023
• Initial Report FDA Received Date: 09/15/2026
• 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