MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ-CEDIV ADMIN SET, 15DRP, 3 NF, 109

Catalog Number	DYNDTB1545
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported finding collapsing easier/air bubbles, with complaints from nurses that the new sku "collapses easier at the chamber and they get more air bubbles when using the port." no sample or photo was received for the investigation; finished good production records and component trending were reviewed, and the manufacturer provided their investigation and did not find any discrepancies within their records or retained samples that could have contributed to the reported issue.The reported defect was unable to be confirmed, as no physical sample or detailed photographic evidence was provided to support the investigation.Root cause has not been identified or determined at this time; the division will monitor this issue for trending purposes, and if a sample, photo, and/or additional information becomes available, this complaint will be reopened to be further investigated.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.
Event or Problem Description
It was reported that "it collapses easier at the chamber and they get more air bubbles when using the port.".

• Brand Name: MEDLINE
• Common Device Name: DBQ-CEDIV ADMIN SET, 15DRP, 3 NF, 109
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: daniel soto ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50914711
• Report Number: 1417592-2026-51918
• Device Sequence Number: 5544712
• Product Code: FPA
• UDI-Device Identifier: 10197344098644
• UDI-Public: 10197344098644
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K242126
• 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): 09/25/2026

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: DYNDTB1545
• Device Lot Number: BQ241157101
• 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: 07/09/2025
• Initial Report FDA Received Date: 09/28/2026
• 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