MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PML,48,ADULT,FLL-MLL,-,OEM

Catalog Number	80641482
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pressure monitoring tubing was stuck together.When customer pulled apart, the tubing split almost all the way through.
Additional Manufacturer Narrative
The account reported finding pressure monitoring lines stuck together, and the customer also included information that they attempted to pull on the line itself and the pml broke into two pieces.A sample of a pressure monitor line (pml) in two pieces was received from the customer for evaluation; finished good production records were reviewed and there were no identified nonconformances that would have contributed to the reported defect, and finished good pack build was reviewed with no changes noted that would have contributed to the reported defect.Because the pml was not returned "stuck together" as reported, medline cannot confirm the reported issue and cannot determine what caused it to be stuck together.Medline will continue to monitor for additional occurrences and adverse trends.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: PML,48,ADULT,FLL-MLL,-,OEM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: donovan frazier ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899004
• Report Number: 1417592-2026-51083
• Device Sequence Number: 10684230
• Product Code: DRI
• UDI-Device Identifier: 10193489067484
• UDI-Public: 10193489067484
• 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): 09/24/2026

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: 80641482
• Device Lot Number: 0000133866
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2025
• 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: 05/30/2025
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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