MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CAUDAL EPIDURAL TRAY

Catalog Number	PAIN1634
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "wings of the 5ml syringe are breaking during use.".
Additional Manufacturer Narrative
The account reported that the wings of the 5ml syringe were breaking during use, and the most recent issue resulted in the provider cutting himself; the customer contact reported the finger was cut through the glove, approximately 0.25¿ laceration, with no impact to the patient or the procedure.A sample was received for investigation, and the 5 ml syringes were removed from three sealed kits and inspected for visible defects, but nothing was noted; force gauge testing found one side of the finger flange broke off on each of two sample syringes with an average of 17.9 lb of force, and production records and pack build review found no issues that would contribute to the reported issue.The reported problem was confirmed during sample testing.Based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process.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: CAUDAL EPIDURAL TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50826049
• Report Number: 1417592-2026-45268
• Device Sequence Number: 13423773
• Product Code: OFT
• UDI-Device Identifier: 40193489311793
• UDI-Public: 40193489311793
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/17/2026

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: PAIN1634
• Device Lot Number: 23CBL321
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/05/2023
• 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: 05/30/2023
• Initial Report FDA Received Date: 09/18/2026
• 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