MAUDE Adverse Event Report: Medline Industries, LP CENTURION; ECMO INSTRUMENT SET

Catalog Number	MNS13620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that item toc7 - tube occluding forcep serrated 7 1/2 has broken 3x already in different sections of the instruments.After opening the mns13620, the clinician went to clamp down on the 3/8 or 1/4 ecmo tubing and the instrument snapped.
Additional Manufacturer Narrative
The account reported finding defective component; the tube occluding forceps serrated 7 1/2 has broken 3x already in different sections of the instruments, and the instrument snapped when the clinician went to clamp down on the 3/8 or 1/4 ecmo tubing.A photo and a sample were received for investigation; one of the arms of the forceps is snapped off and was in pieces, production records were reviewed with no non-conformances noted, and the bom was reviewed and found no issues.The sample provided did confirm that the forcep was broken.At this time it is unable to determine the cause of the broken forcep; the vendor states it is possible for a minute crack to form in the instrument during their hammering process, and the manufacturer of the item has implemented a stress test as part of their final inspection.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: ECMO INSTRUMENT SET
• Manufacturer (Section D): Medline Industries, LP; 301 catrell drive; howell MI 48843 -170
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50852471
• Report Number: 1417592-2026-47245
• Device Sequence Number: 18648300
• Product Code: LRP
• UDI-Device Identifier: 00653160350241
• UDI-Public: 00653160350241
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/21/2026

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: MNS13620
• Device Lot Number: 2023042490
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/30/2023
• 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: 11/17/2023
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown