MAUDE Adverse Event Report: Medline Industries LP MEDLINE; DBD-NEURO CATH PACK NCLUA227-LF

Catalog Number	DYNJ47646J
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that component 99020 ¿ this is the waste bag that is causing issues.Per namic rep- as we discovered, the waste bag with the reflux valve that is showing up in your packs is not the preferred item and is also causing issues with connectivity of the syringe onto the reflux piece.
Additional Manufacturer Narrative
The account reported that the waste bag with the reflux valve showing up in the packs was not the preferred item and was causing issues with connectivity of the syringe onto the reflux piece.No sample or photo was received for the investigation; finished good production records and finished good pack build were reviewed, and there were no line down situations, deviations, run-without, or non-conformance reports that might have had an impact on this issue.The reported connectivity issue could not be evaluated without a sample or photo; the dhr review found the waste bag with the reflux valve was an approved substitution, and the cause code was adjusted to dc: traced to user with approved specification change.Medline determined that the form, fit, and function of the subbed item is equivalent with the original item that was subbed out, the pack was built according to specifications at the time it was produced, and the incident was found to be acceptable.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-NEURO CATH PACK NCLUA227-LF
• Manufacturer (Section D): Medline Industries LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: arthem smalyukh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50234726
• Report Number: 1417592-2026-16601
• Device Sequence Number: 21396595
• Product Code: LRO
• UDI-Device Identifier: 10198459191961
• UDI-Public: 10198459191961
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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: DYNJ47646J
• Device Lot Number: 25BMH613
• 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: 05/08/2025
• Initial Report FDA Received Date: 08/13/2026
• 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