MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DR D SINGLE SHOT EPIDURAL TRAY

Catalog Number	PAIN2121
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that chloraprep stick arrived cracked, no prep came out of stick and it felt dry.Glass completely exploded inside the chloraprep stick.
Additional Manufacturer Narrative
The account reported that the chloraprep stick arrived cracked, no prep came out of the stick and it felt dry, and glass completely exploded inside the chloraprep stick.A photo and a sample were received; medline was not able to determine anything with the photo received, and upon gently shaking the unit, something damaged could be heard inside the unit.Finished good production records and finished good pack build were reviewed, and there were no issues identified that would contribute to the reported issue; the unit cannot be further tested.Based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process; 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: DR D SINGLE SHOT EPIDURAL TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854339
• Report Number: 1417592-2026-47491
• Device Sequence Number: 21220794
• Product Code: OFT
• UDI-Device Identifier: 10198459036262
• UDI-Public: 10198459036262
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/21/2026

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: PAIN2121
• Device Lot Number: 25CBF463
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2025
• 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: 05/08/2025
• Initial Report FDA Received Date: 09/22/2026
• 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