MAUDE Adverse Event Report: Medline Industries, LP NAMIC; MTS,CLOSED,SYSTEM-PARKVIEW HOSPITAL

Catalog Number	60160372
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it is the 3 way stopcock from the saline to the waste bag.Ll does not tighten and is leaking.".
Additional Manufacturer Narrative
The customer reported the 3 w stopcock from the saline to the waste bag; the luer lock does not tighten and is leaking.No stock check was able to be performed as there was no remaining inventory, and a used sample was returned for evaluation; visual evaluation revealed the stopcock to not be seated properly at the bond site, while review of the finished good bill of materials/pack build, manufacturing instructions, drawing, and device history records did not reveal nonconformances related to the reported defect.Based on the investigation results, the reported event was confirmed as the stopcock was not bonded onto the assembly straight and secure.Root cause can be attributed to human error, and 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: NAMIC
• Common Device Name: MTS,CLOSED,SYSTEM-PARKVIEW HOSPITAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945920
• Report Number: 1417592-2026-54157
• Device Sequence Number: 15827392
• Product Code: OEZ
• UDI-Device Identifier: 20193489048725
• UDI-Public: 20193489048725
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/29/2026

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: 60160372
• Device Lot Number: 0000117599
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/06/2025
• 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: 12/17/2024
• Initial Report FDA Received Date: 09/30/2026
• 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