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

Catalog Number	000000000090701482
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "arterial lines are backing up with blood and when the staff investigate the system, they are finding small cracks in the pressure monitoring tubing causing the tubing to leak and the blood to back up into the line.".
Additional Manufacturer Narrative
The reporter described issues with pressure monitoring tubing in the picu, where arterial lines were backing up with blood and staff were finding small cracks in the pressure monitoring tubing causing the tubing to leak.A review of the device history records was performed for the indicated packaging and component lots, and the returned sample was found to have a crack in the female fitting of the pressure monitoring line.The complaint is confirmed for a cracked pml fitting.Possible root cause may be that the end user did not adequately secure connections between the pressure monitoring line and the device they were connecting to were not "finger tightened" prior to use; root cause could not be determined, and dhr review revealed no quality related issues or manufacturing deficiencies at the time of manufacture.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,PG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915441
• Report Number: 1417592-2026-52003
• Device Sequence Number: 5394599
• Product Code: DRI
• UDI-Device Identifier: 20193489068334
• UDI-Public: 20193489068334
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 09/25/2026

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: 000000000090701482
• Device Lot Number: 0000085936
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/28/2023
• 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: 11/17/2023
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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