MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-IV ADMIN SET, 15DRP, 2 NF PORTS, 96"

Catalog Number	DYNDTN1512
Medical Device Problem Codes	Complete Blockage (1094); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "tubing sealed at the opening and fluid is unable to go though the tubing".
Additional Manufacturer Narrative
The account reported finding tubing sealed at opening and fluid was unable to go through the tubing.The customer returned 2ea opened and unused product; upon visual inspection, both samples appeared to have kinking/sealing of the tube underneath the drip chamber, and each sample was connected to a saline iv bag to test if fluid was able to push through the product.Based on the complaint details, sample evaluation, and investigation, the issue can be confirmed; during visual inspection and testing of the returned products, a seal of the tubing underneath the drip chamber was identified, and fluid was not able to flow through the product.At this time, a root cause for the issue cannot be identified, and the manufacturer provided their investigation and did not find any discrepancies within their records or retained samples that could've contributed to the reported issue; supplier quality team will also monitor this issue for trending purposes.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: DBD-IV ADMIN SET, 15DRP, 2 NF PORTS, 96"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50935172
• Report Number: 1417592-2026-53469
• Device Sequence Number: 10749758
• Product Code: FPA
• UDI-Device Identifier: 10080196760091
• UDI-Public: 10080196760091
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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: DYNDTN1512
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2025
• 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: 02/05/2025
• Initial Report FDA Received Date: 09/29/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown