MAUDE Adverse Event Report: Medline Industries, LP NAMIC; COMP,3V,200S,RH,OFF,OEM,PG

Catalog Number	80058307
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	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the procedure, the ring detaches from the tap block (see photo).".
Additional Manufacturer Narrative
The account reported finding ra separated from manifold, and the complaint stated that the issue occurred during use and no injury occurred.A photo was received to aid the investigation; no physical sample was available, finished good production records were reviewed, and finished good pack build records were reviewed with no non-conformances noted that would have contributed to the reported issue.Based on the information provided and review of the photo received from the customer, the report of an ra separated from the manifold can be confirmed.However, without the physical sample available for review, it is impossible to determine if there was a successful swage of the ra to the manifold stem, therefore, the root cause could not be identified; the division will monitor this issue for trending purposes.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: COMP,3V,200S,RH,OFF,OEM,PG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854266
• Report Number: 1417592-2026-47477
• Device Sequence Number: 10053633
• Product Code: DRS
• UDI-Device Identifier: 10193489066708
• UDI-Public: 10193489066708
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K902472
• 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): 09/22/2026

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: 80058307
• Device Lot Number: 0000136208
• Was Device Available for Evaluation?: No
• 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: 07/28/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (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