MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-BLOCK KIT/OR

Catalog Number	DYNJRA2112
Medical Device Problem Codes	Obstruction of Flow (2423); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "18 g needle bent" and "25g needle bent.".
Additional Manufacturer Narrative
The customer reported the needle "bent" and the filter straws were "clogged," and reported "no patients were harmed and items not used besides the filter straws." a sample was received consisting of one 18gx1.5in reg bevel needle and five filter straw, 5 micron long; the 18g needle was inspected for any signs of being bent, but the needle is straight, and each filter straw has a pinched/kinked section approximately 25mm from the end of the tubing.The reported bent 18g needle was not confirmed, and the filter straw condition was confirmed.Based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process; there has been no change to the reportability decision associated with this complaint.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-BLOCK KIT/OR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50858997
• Report Number: 1417592-2026-48168
• Device Sequence Number: 9553575
• Product Code: OFT
• UDI-Device Identifier: 40195327323173
• UDI-Public: 40195327323173
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 09/22/2026

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: DYNJRA2112
• Device Lot Number: 23IBP988
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/15/2024
• 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: 03/04/2024
• Initial Report FDA Received Date: 09/22/2026
• 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