MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MTS,RIGHT HEART,KIT,PENINSULA,REG MED

Catalog Number	60160427
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	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿rotating adaptor on the manifold is disconnecting from the manifold when they power inject.¿.
Additional Manufacturer Narrative
According to the facility the product was being used in a left heart case; they were performing and lv gram and power injected through the manifold at 600 psi, and the rotating adaptor on the manifold came off the manifold.No sample or photo was received for the investigation; the packs production record could not be reviewed as no lot number was reported, and the bill of materials (bom) and packaging instructions were reviewed with no change to the bom or placement of components that would have contributed to the reported defects.At this time, medline was unable to confirm the reported defects, as no physical samples or detailed photographic evidence was provided to support the investigation; the cause was unconfirmed, with sample required to determine cause.The division will monitor this issue for trending purposes, and there has been no change to the reportability decision associated with this complaint.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,RIGHT HEART,KIT,PENINSULA,REG MED
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945323
• Report Number: 1417592-2026-54059
• Device Sequence Number: 9624353
• Product Code: OEZ
• UDI-Device Identifier: 10193489048766
• UDI-Public: 10193489048766
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/28/2026

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: 60160427
• Was Device Available for Evaluation?: Yes
• 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: 01/13/2026
• Initial Report FDA Received Date: 09/30/2026
• 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