MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET, 6.5", 0.7ML, NONBOND NF

Catalog Number	DYNDTC5077
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "while the nurse was pushing contrast thru the tubing that it ended up bursting thru the tubing, this isnt the first time it has happened.".
Additional Manufacturer Narrative
The customer reported finding tubing burst while a nurse was pushing contrast through the tubing; the device was used on a patient, with no impact to the patient, provider or procedure, no serious injury, medical intervention, or follow-up care, and potential for emboli.A photo and a sample were received for investigation, visual inspection was performed, and finished good production records were reviewed.The reported issue was confirmed as the burst tubing was observed on the right beside the clamp.The root cause was found to not be a quality defect because the returned product was used with pressure injection, dyndtc5077 is not pressure-rated, and should only be used under gravity iv infusion; therefore, since the returned product was not used appropriately, the issue could not be confirmed to be a quality defect of the product.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: IV EXT SET, 6.5", 0.7ML, NONBOND NF
• 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: 50899179
• Report Number: 1417592-2026-51126
• Device Sequence Number: 10761500
• Product Code: FPA
• UDI-Device Identifier: 40080196141884
• UDI-Public: 40080196141884
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 09/24/2026

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: DYNDTC5077
• Device Lot Number: 24066618
• 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: 12/13/2024
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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