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

Catalog Number	DYNDTC5077
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Unspecified Vascular Problem (4441); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the iv set was fallen part, cap will not break, malfunction, 50% of them" and "-blowing the vein especially when trying to clamp or attach to iv catheter -leaking around catheter attachment -difficult to bend resulting in the tubing becoming kinked and no longer allowing fluid to flow -clave is detached or falls off when opening package.".
Additional Manufacturer Narrative
The customer reported the iv set was "falling apart," "cap will not break," "malfunction, 50% of them," and issues included "blowing the vein especially when trying to clamp or attach to iv catheter," "leaking around catheter attachment," "difficult to bend resulting in the tubing becoming kinked and no longer allowing fluid to flow," and "clave is detached or falls off when opening package." at this time, a sample(s) was not received for investigation; investigation included review of recent complaint trends, and objectionable trends were not seen for this issue.The complaint was not confirmed.Sample required to determine cause; no further action was taken.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: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50852321
• Report Number: 1417592-2026-47232
• Device Sequence Number: 18554661
• Product Code: FPA
• UDI-Device Identifier: 40080196141884
• UDI-Public: 40080196141884
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 09/21/2026

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: 22075869
• Was Device Available for Evaluation?: Yes
• 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: 07/21/2023
• Initial Report FDA Received Date: 09/22/2026
• 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