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

Catalog Number	PAIN1644
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the thread does not fit through the connector for this lot number.The doctors have had to open multiple trays to get it to work.".
Additional Manufacturer Narrative
The account reported that the thread does not fit through the connector, and the doctors have had to open multiple trays to get it to work.Samples were received for investigation, were in good condition, and were tested to see if the catheter could be inserted and locked in place; the samples failed their test due to the catheter not being able to be loaded into the connector the proper length.The reported problem was confirmed based on the sample evaluation, and the catheter ended up being approximately 6-8mm short of the mark.Based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process; this complaint has been provided to the vendor for further evaluation and the quality team 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 CATHETERIZATION KIT
• 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: 50895946
• Report Number: 1417592-2026-50676
• Device Sequence Number: 6001006
• Product Code: OEZ
• UDI-Device Identifier: 40193489331142
• UDI-Public: 40193489331142
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: PAIN1644
• Device Lot Number: 23CLA104
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2023
• 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: 04/20/2023
• 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