MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET, 8", 0.3ML, NONBOND NF VA

Catalog Number	DYNDTC5081
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, ¿when we have to push saline or meds, sometimes it does not allow you to.We have to disconnect and reconnect several times before we can do iv push.The problem seems to be in the stopper of these iv extenders.¿.
Additional Manufacturer Narrative
The customer reported that when they have to push saline or meds, ¿sometimes it does not allow you to,¿ and they ¿have to disconnect and reconnect several times before we can do iv push.¿ medline received 1 case of iv extension set; 10 were selected randomly for testing, visual inspection found no noticeable defects nor any cosmetic damage, and flushing was attempted with 10/10 succeeded in this function.The complaint was not confirmed.No further action was taken because objectionable trends were not seen for this issue, and the division has been informed and will continue to monitor trends.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, 8", 0.3ML, NONBOND NF VA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898435
• Report Number: 1417592-2026-50995
• Device Sequence Number: 18819453
• Product Code: FPA
• UDI-Device Identifier: 40080196141914
• UDI-Public: 40080196141914
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: DYNDTC5081
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/22/2023
• 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: 07/25/2023
• 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