MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LHK-SETON MEDICAL CENTER,AUSTI

Catalog Number	VASC1803
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "transducer is warped and bent at the top of the male leur lock connection".
Additional Manufacturer Narrative
The reported issue was that the edwards transducer is warped and bent at the top of the male leur lock connection; the issue did not occur during use and no injury occurred.No sample or photo was received for the investigation; finished good production records, the bill of materials (bom), packaging instructions, account complaint history, and component complaint history were reviewed.At this time, the reported defect could not be confirmed, as no physical sample or detailed photographic evidence was provided, and the cause was documented as sample required to determine cause.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: MEDLINE
• Common Device Name: LHK-SETON MEDICAL CENTER,AUSTI
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946431
• Report Number: 1417592-2026-54252
• Device Sequence Number: 9534263
• Product Code: DRS
• UDI-Device Identifier: 10198459398117
• UDI-Public: 10198459398117
• 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): 09/29/2026

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: VASC1803
• Device Lot Number: 25HBL083
• Was Device Available for Evaluation?: No
• 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: 10/17/2025
• Initial Report FDA Received Date: 09/30/2026
• 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