MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; DBD-DRIVELINE DRESSING KIT

Catalog Number	DM470B
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have a patient that it appears has a tear in his driveline dressing as pictured below." "after we discovered this, we did another dressing change and, using one finger, was able to scratch two tears into the clear dressing in two separate areas.".
Additional Manufacturer Narrative
The customer reported a sorbaview dressing that tore while on the patient, and that the customer opened another kit, scratched at the window of the sv733, and it tore too easily.A photo was received for the investigation; no physical sample was available, and retains from the same lot that was used in the complaint were requested from the manufacturing facility for evaluation.The photo confirmed the customer¿s report, but retained samples were inspected, applied to a test surface, and removed with no signs of tearing or unexpected film behavior observed.At this time, the root cause cannot be determined, and 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: CENTURION
• Common Device Name: DBD-DRIVELINE DRESSING 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: 50912930
• Report Number: 1824619-2026-00110
• Device Sequence Number: 5330355
• Product Code: OXQ
• UDI-Device Identifier: 10653160381358
• UDI-Public: 10653160381358
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: DM470B
• Device Lot Number: 2025080190
• 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: 11/06/2025
• 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