MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET,60",0.6ML, M/F LUERLOCK,CLAMP

Catalog Number	DYNDTN0007
Medical Device Problem Codes	Priming Problem (4040); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tubing causing bubbles and high pressure alarm and difficulty manually priming before inserted into pump.
Additional Manufacturer Narrative
Customer reported tubing causing bubbles and high pressure alarm and difficulty manually priming before inserted into pump.Medline quality received 1 ea of dyndtn0007 for evaluation, and visual inspection was conducted with the provided samples.Due to the usage of the device, medline was unable to confirm the complaint; dyndtn0007 is not a pressure-rated set and is to be used only with gravity iv infusion, and the cause code was dc:traced to user - preference/item to spec.A retrospective review of the past two years for this product indicated that there have been no prior complaints in regard to this issue, and the division will continue to monitor the issue for trending.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,60",0.6ML, M/F LUERLOCK,CLAMP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945124
• Report Number: 1417592-2026-54031
• Device Sequence Number: 15827483
• Product Code: FPA
• UDI-Device Identifier: 20080196760166
• UDI-Public: 20080196760166
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 09/29/2026

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: DYNDTN0007
• Device Lot Number: 23105484
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/03/2024
• 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: 03/22/2024
• Initial Report FDA Received Date: 09/30/2026
• 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