MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-CATHETER, IV, SURESITE AUTO, 22G X 1

Catalog Number	DYNA22100
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Expulsion (2933)
Health Effect - Clinical Code	Unintended Loss of Vascular Access (4867)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it would automatically come out of the patient's arm.Catheter would come out and it was tapped down with tegaderm.".
Additional Manufacturer Narrative
The account reported the catheter would come out of the patient's arm even though it was taped down, and it happened during the power injection phase.A sample was received for investigation; 3 boxes of product were received from the customer and sent to the vendor for investigation, and the vendor reviewed batch manufacturing records, supplier verification, control samples, visual inspection, gripping of needle with catheter, pull test of the catheter, and penetration test.The complaint was not confirmed, as the item is not intended for use with power injection, and the manufacturer did not find any discrepancies within their records or retained samples that could have contributed to the reported issue.No root cause was identified, and the division will continue to monitor the issue for trending.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: DBD-CATHETER, IV, SURESITE AUTO, 22G X 1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50866467
• Report Number: 1417592-2026-48472
• Device Sequence Number: 21160784
• Product Code: FOZ
• UDI-Device Identifier: 30193489140075
• UDI-Public: 30193489140075
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161779
• 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: DYNA22100
• Device Lot Number: 27823100001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2024
• 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: 11/14/2024
• Initial Report FDA Received Date: 09/23/2026
• 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