MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MTS,LEFT,HRT,KIT-SHASTA,REGIONAL

Catalog Number	000000000060131831
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	03/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "two manifolds broke during a power injection.".
Additional Manufacturer Narrative
The account reported finding broken manifold during a power injection.One sample perceptor manifold was received for evaluation; finished good production records, finished good pack build, and trending were reviewed.The visual inspection found the rotating adaptor (ra) to be separated from the manifold body, confirming the reported issue.Manifold specs are 200 psi static, 750 psi dynamic, not intended for use with power injection, and based on the complaint intake reporting of the event provided by the customer, this 200s manifold was being used outside of its intended design specs, with a power injector; there was no confirmed medical intervention or serious injury reported related to this incident.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: MTS,LEFT,HRT,KIT-SHASTA,REGIONAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946320
• Report Number: 1417592-2026-54225
• Device Sequence Number: 10429566
• Product Code: OEZ
• UDI-Device Identifier: 10193489047097
• UDI-Public: 10193489047097
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 000000000060131831
• Device Lot Number: 0000149038
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2025
• 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: 03/08/2025
• 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