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

Catalog Number	DYNDTC5077
Medical Device Problem Codes	Disconnection (1171); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the peripheral iv lock came apart multiple times while setting up iv lines for patient and came apart while attached to a patient in the recovery room.".
Additional Manufacturer Narrative
The customer reported that this part of the saline lock has come apart quite frequently in the last month and came apart while hooked up to the patient in the recovery room; the line was sanitized with alcohol and hooked back up to patient, no serious injury, medical intervention, or follow-up care was reported, the patient is fine, and the procedure/medication administration was completed.The customer provided a sample for evaluation, but the sample was either lost or misplaced; the division pulled 3ea of the item for testing, attached the female luer to the male luer of an iv admin set, attached the whole setup to an iv bag, and flushed fluid through each sample for around 30 minutes.For all the samples, the needless connector did not come off or become loose, and based on the complaint details, sample evaluation and investigation, the issue cannot be confirmed.The vendor responded that, by design, the set is designed to allow for the valve to be removed, as it is non-bonded, and medline concluded the item remained attached to the iv admin set for the entirety of testing and recommended use with an iv admin set that can screw onto the female end of the device to avoid possible instances of separation.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: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854941
• Report Number: 1417592-2026-47612
• Device Sequence Number: 9508112
• Product Code: FPA
• UDI-Device Identifier: 40080196141884
• UDI-Public: 40080196141884
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2024
• 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: 06/19/2024
• 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