MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRAPE,UNDERBUTTOCK,PCH,ST,20/CS

Catalog Number	DYNJP6002
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the under buttocks drape with drainage pouch was leaking all over the floor.
Additional Manufacturer Narrative
The customer reported the under buttocks drape was leaking fluid at the sealed bottom of pouch; there was no impact to the patient or user, but towels were required to soak up the fluid on the floor and they could not accurately gauge how much fluid was drained from the patient.The photo was reviewed, samples from the local branch were reviewed, the contract manufacturer was sent the investigation form, and analysis of complaint data was performed; the samples from the branch were inspected and found to meet the product specifications, and medline was unable to duplicate the reported issue when the pouches were tested by putting fluid into them.Based on the results of the investigation the issue is confirmed, but without the sample medline is unable to determine the root cause of the leaking.The manufacturing investigation found that the machine for hot sealing the port was shut down for 3 to 5 minutes and that the worker did not warm up the machine after the power was restored, which may have caused poor seals around the port; based on the investigation results, 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: DRAPE,UNDERBUTTOCK,PCH,ST,20/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50613652
• Report Number: 1417592-2026-32420
• Device Sequence Number: 21476086
• Product Code: PUI
• UDI-Device Identifier: 10080196739455
• UDI-Public: 10080196739455
• 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): 09/02/2026

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: DYNJP6002
• Device Lot Number: 30524080044
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• 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