MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-CATHETER, IV, SURESITE AUTO, 24G X 0

Catalog Number	DYNA24075Z
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needles are not retracting cleanly from catheter causing the catheter to be pulled out of vein when retracting needle.".
Additional Manufacturer Narrative
The account reported finding defective needles, with anita morgan "reporting the needles are not retracting cleanly." a sample was received for investigation; the returned samples could not be investigated through internal testing due to the absence of validated test methods, established specifications, and/or appropriate equipment necessary to evaluate the component against its requirements.The manufacturer did not find any discrepancies or defects in their production records or retained samples that could have contributed or caused the reported issue, and found that the catheters retracted as intended (per the ifu) when catheter is slightly advanced off the needle prior to retraction.Based on the manufacturer's investigation, the complaint is now unconfirmed, since the reported issue was unable to be replicated during the manufacturer's evaluation of the returned samples.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, 24G X 0
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50916187
• Report Number: 1417592-2026-52108
• Device Sequence Number: 5544764
• Product Code: FOZ
• UDI-Device Identifier: 10193489140057
• UDI-Public: 10193489140057
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/25/2026

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: DYNA24075Z
• Device Lot Number: 27823100007
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2026
• 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: 03/16/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (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