MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-EPIDURAL,SINGLE SHOT,18G

Catalog Number	PAIN2025A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the outside box had a hole in it and it looks like whatever caused that hole also caused one of trays to have a hole in it.The worms though were not inside the trays only found in the outer box.".
Additional Manufacturer Narrative
The customer reported "the outside box had a hole in it" and "whatever caused that hole also caused one of trays to have a hole in it," and stated "the worms though were not inside the trays only found in the outer box." medline logged the issue with quality assurance and stated this was not a quality issue; it was filed with osi (operation service issues), which takes care of physical shipping damage and/or concealed damage products and will perform an investigation.No product examination results or confirmed finding were documented in the investigation details.The complaint file listed the cause as "dc:cause traced to transport/storage - osi: shipping damage, medline facility," and medline stated the quality file would be closed.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,SINGLE SHOT,18G
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50777875
• Report Number: 1417592-2026-41211
• Device Sequence Number: 9826355
• Product Code: OFT
• UDI-Device Identifier: 10195327673697
• UDI-Public: 10195327673697
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/14/2026

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: PAIN2025A
• Device Lot Number: 25DBR243
• Was Device Available for Evaluation?: Yes
• 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: 07/24/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown