MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; AVA HF 9FR 11CM BUNDLE

Catalog Number	ECVC8355
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cvicu received the patient from the cvor and noticed on the chest x-ray the ava hf was kinked internally.
Additional Manufacturer Narrative
The customer reported that cvicu received the patient from the cvor and noticed on the chest x-ray the ava hf was kinked internally; no serious injury was noted, the line was removed, and no medication was missed due to leaking.Two samples were received from the customer and confirmed the customer's report of kinking of the catheter tubing; centurion's engineering team measured the catheter sheath wall thickness for both returned samples and confirmed the wall thickness was within the specification defined on the drawing, and production records review found no nonconformances related to the component.Based on the complaint details, sample evaluation, and investigation, the complaint was confirmed.While the reported issue of kinking could be confirmed, the root cause for the kinking was unable to be determined, and the supplier quality team 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: MEDLINE
• Common Device Name: AVA HF 9FR 11CM BUNDLE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50857611
• Report Number: 1417592-2026-48028
• Device Sequence Number: 10053229
• Product Code: LRO
• UDI-Device Identifier: 00653160378917
• UDI-Public: 00653160378917
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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): 09/22/2026

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: ECVC8355
• Device Lot Number: 2024022690
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2025
• 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: 12/11/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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