MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-CATHETER,IV,SURESITE SLIDE,18G X 1 1

Catalog Number	DYNSCS18114
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the catheter bent inside of the patient and started to shake apart once catheter was removed from the patient.".
Additional Manufacturer Narrative
According to the facility, an associate was inserting a peripheral iv via ultrasound when the catheter bent inside of the patient and started shearing once the nurse pulled it out of the patient; patient was not harmed, patient is doing "fine," and no medical intervention, serious injury, or follow-up care has been reported.No sample or photo was received for the investigation; finished good production records and trending were reviewed, and 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.Based on the complaint details and evaluation, the complaint is not confirmed.The investigation was limited without receipt of the physical sample or detailed photographic evidence from the customer, and the complaint remains unconfirmed.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 SLIDE,18G X 1 1
• 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: 50867001
• Report Number: 1417592-2026-48516
• Device Sequence Number: 21160789
• Product Code: FOZ
• UDI-Device Identifier: 10888277667518
• UDI-Public: 10888277667518
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150611
• 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: DYNSCS18114
• Device Lot Number: 27825080003
• 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: 03/11/2026
• 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