MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; DBD-VANTEX 7FR 16CM 3L CVC STOCK+ BUNDLE

Catalog Number	ECVC6690
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the probe cover inside the medline central line kit is splitting down the seam when being secured, thus causing a break in sterile field.".
Additional Manufacturer Narrative
Provider/staff reported today that the probe cover inside the medline central line kit is splitting down the seam when being secured, thus causing a break in sterile field; it wasn¿t used on patient, no harm, but split when putting on probe.The package with the customer returned sample was received but was unable to be located for sample evaluation, and centurion's complaint history and production data were reviewed with no similar complaints reported.Based on the review of the details provided for the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications.At this time, the root cause cannot be determined, and this issue will continue to be monitored by centurion¿s complaint system.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-VANTEX 7FR 16CM 3L CVC STOCK+ BUNDLE
• 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: 50934831
• Report Number: 1824619-2026-00129
• Device Sequence Number: 13159108
• Product Code: LRO
• UDI-Device Identifier: 10653160320432
• UDI-Public: 10653160320432
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: ECVC6690
• Device Lot Number: 2024020690
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2024
• 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: 07/09/2024
• Initial Report FDA Received Date: 09/29/2026
• 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