MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-POLY MIDLINE KIT 4F SL

Catalog Number	DYNJ68937A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿it kinda coiled up.Like if you were to smash a straw down, what the tip would look like.The dilator had a lot of resistance.¿.
Additional Manufacturer Narrative
The customer reported that the dilator ¿kinda coiled up¿ and ¿had a lot of resistance¿; no patient was harmed.Visual examination of the returned sample confirmed the customer¿s report, some curling at the tip of the introducer was observed, and a review of the production records did not find any nonconformances noted by production or quality control personnel during first article, in-process, or case packaging inspections.The reported problem was confirmed; based on the information currently available, a root cause cannot be positively identified at this time.The vendor was also contacted concerning the issue and the complaint sample has been forwarded to them for further investigation.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-POLY MIDLINE KIT 4F SL
• 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: 50896095
• Report Number: 1417592-2026-50688
• Device Sequence Number: 13452340
• Product Code: LRS
• UDI-Device Identifier: 20193489111542
• UDI-Public: 20193489111542
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/24/2026

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: DYNJ68937A
• Device Lot Number: 2022031050
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2023
• 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: 02/01/2023
• Initial Report FDA Received Date: 09/25/2026
• 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