MAUDE Adverse Event Report: Medline Industries, LP NAMIC; LHK,-,PRM,3V,ON,DT,PS,CMSQ,S10RA

Catalog Number	613000163
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "have had atleast three kits now that have had a part of the ao line break off when we are getting the set ready to use.They all are coming from the same lot number.".
Additional Manufacturer Narrative
The customer reported that at least three kits had a part of the ao line break off when getting the set ready to use, and they all came from the same lot number.Three (3) used samples were returned for evaluation, and visual evaluation of the returned samples revealed the stopcocks broken from the assembly at the bond joint; reviews of the finished good bill of materials/pack build, finished good 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 three (3) assemblies broken at the bond joint.Although inconclusive, possible root cause can be attributed to either excessive handling or force experienced during shipping or at time of use during the procedure/setup; no action is required at this time, 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: LHK,-,PRM,3V,ON,DT,PS,CMSQ,S10RA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50914395
• Report Number: 1417592-2026-51877
• Device Sequence Number: 5393518
• Product Code: OEZ
• UDI-Device Identifier: 20193489074557
• UDI-Public: 20193489074557
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 613000163
• Device Lot Number: 0000102804
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2024
• 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: 03/26/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown