MAUDE Adverse Event Report: Medline Industries, LP NAMIC; MTS,LHK,DIGNITY,FRENCH HOSP

Catalog Number	000000006012112841
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported ra separated from manifold.Investigation included review of the photo and evaluation of a used sample; review of the finished good bill of materials/pack build, finished good manufacturing instructions, drawing, device history records, receiving inspection records, related changes, and complaint history did not reveal any related nonconformances or adverse trend.The reported defect was confirmed as the ra separated from the manifold.Further communication with the sales rep and customer discovered the 200 series manifold was being used outside the intended design specs, as the psi was too extreme for this specific manifold, therefore causing the ra to separate; root cause can be attributed to user knowledge, with the updated cause code adjusted to traced to user with misuse/mishandling.There were no reports of death, serious injury, medical intervention, or follow up care.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.
Event or Problem Description
It was reported that ra separated from manifold.

• Brand Name: NAMIC
• Common Device Name: MTS,LHK,DIGNITY,FRENCH HOSP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947914
• Report Number: 1417592-2026-54512
• Device Sequence Number: 10446675
• Product Code: OEZ
• UDI-Device Identifier: 20193489096146
• UDI-Public: 20193489096146
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 000000006012112841
• Device Lot Number: 0000129111
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/26/2024
• 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: 09/16/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (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