MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; LVAD KIT

Catalog Number	DM1285A
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the gloves were included on the outside of the kit, thus compromising the sterility.".
Additional Manufacturer Narrative
The customer reported finding incorrect assembly, and the customer provided images of the loose gloves and packaging slip.A photo and a sample were received for investigation; finished good production records and the bill of materials were reviewed, and trending and component trending were reviewed.Samples and pictures provided by the customer confirm that the lvad kit was produced with non-walleted gloves, and the gloves were located inside the sterile kit packaging.The root cause is a component substitution issue; this is not a kit sterility issue, but may impact sterility of the components during use by the end user, and production and qc managers have been notified of the reported issue.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: CENTURION
• Common Device Name: LVAD KIT
• Manufacturer (Section D): Centurion Medical Products, LP; 301 catrell drive; howell MI 48843 -170
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945864
• Report Number: 1824619-2026-00147
• Device Sequence Number: 13167726
• Product Code: LRP
• UDI-Device Identifier: 10653160367543
• UDI-Public: 10653160367543
• 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: DM1285A
• Device Lot Number: 2025021790
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2025
• 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: 04/21/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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