MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MTS,4,PORT,KIT-PROVIDENCE,ALASKA MED CEN

Catalog Number	000000000060160011
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	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when they injected, the end connection blew right off, and they were unable to use.".
Additional Manufacturer Narrative
The account reported ra separated from manifold body, and additional information stated they were power injecting but did not recall at what pressure.No sample was received for evaluation; a review of the product drawing and device history record were performed and determined to meet product specifications, with no non-conformances identified that would have contributed to the reported defect.Without a photo or sample, the reported issue and root cause could not be confirmed at this time.Based on the review of the dhr and drawing, the item meets specifications; additional information revealed this 200s manifold was being used outside the intended design specs, with a power injector, and the manifold is not intended for use with power injection.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,4,PORT,KIT-PROVIDENCE,ALASKA MED CEN
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913467
• Report Number: 1417592-2026-51805
• Device Sequence Number: 17641991
• Product Code: OEZ
• UDI-Device Identifier: 10193489048605
• UDI-Public: 10193489048605
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: 000000000060160011
• Device Lot Number: 0000146460
• 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: 02/11/2025
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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