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

Catalog Number	PAIN1910
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "about 50% of the time, the extension tube on these extension sets is bent.They are never 100% bent/crimped so that they are occluded, but the end-users are concerned that this could pose a risk.".
Additional Manufacturer Narrative
This is a combination product it was reported that about 50% of the time, the extension tube on these extension sets is bent and they are never 100% bent/crimped so that they are occluded.A sample was received and consisted of six (6) extension sets not in their original packaging; each extension set had a bend/crimp, two of them had two bends/crimps, and the bend/crimp does not appear to block fluid flow, but does hinder it.The reported problem was confirmed.Finished good production records and finished good pack build were reviewed with no issues that would contribute to the reported issue; based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process or the item was damaged prior to placement in the pack and was not noted during assembly, and the complaint was provided to the component manufacturing facility for further evaluation while quality will 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-EPIDURAL KIT/OR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50889018
• Report Number: 1417592-2026-50454
• Device Sequence Number: 13427842
• Product Code: OFT
• UDI-Device Identifier: 40195327323234
• UDI-Public: 40195327323234
• Combination Product (Y/N): Y
• 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): 09/24/2026

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: PAIN1910
• Device Lot Number: 23CBK201
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2023
• 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: 09/06/2023
• Initial Report FDA Received Date: 09/24/2026
• 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