MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-535734 CONTINUOUS EPIDURAL

Catalog Number	PAIN1052A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "a leaking item in the epidural tray item# pain1052a" and "it has been happening quit a bit.".
Additional Manufacturer Narrative
The account reported a leaking item in the epidural tray and stated it has been happening quite a bit.A photo and a sample were received; the pack arrived open, there was a large stain on the csr wrap, and upon unwrapping the pack, the chloraprep applicator was seen as the reason for the stain; the applicator was still sealed but had been prematurely activated, and other components had some of the chloraprep stain on them.Finished good production records and pack build history were reviewed with no line down situations, run without approvals, substitutions, deviations, non-conformance reports, or pack build issues that might have had an impact; based on the sample evaluation, the reported problem was confirmed.The placement of the chloraprep in the pack was reviewed and its location may have contributed to the pre-activation, components may also become damaged during transit or storage, and there is not enough information to provide a true root cause; the quality team will monitor this issue for trending purposes and production and qc managers have been notified.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-535734 CONTINUOUS EPIDURAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946371
• Report Number: 1417592-2026-54237
• Device Sequence Number: 13149560
• Product Code: OGE
• UDI-Device Identifier: 40889942685241
• UDI-Public: 40889942685241
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/29/2026

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: PAIN1052A
• Device Lot Number: 24JLA647
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/18/2024
• 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: 12/13/2024
• Initial Report FDA Received Date: 09/30/2026
• 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