MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ANTERIOR HIP PACK

Catalog Number	DYNJ49189G
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "dynj49189g lot 23cmh812 with a non-sterile item packed in a non sterile labeled pouch on the back of a sterile pack".
Additional Manufacturer Narrative
The account reported finding a non-sterile item in a pouch.Medline received two photos and no physical sample was available; the drape component was observed removed from its original packaging and placed inside the poly bag pouch, and the finished good production records and finished good pack build were reviewed.The reported issue was confirmed based on the photo evaluation.Based on the complaint details it is likely the non-sterile item placement inside the pouch was a human error during the manual pack assembly process; production and qc managers were notified, feedback will be provided to the build team, and the issue will be monitored 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-ANTERIOR HIP PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50789899
• Report Number: 1417592-2026-42317
• Device Sequence Number: 16094720
• Product Code: OJH
• UDI-Device Identifier: 40195327150571
• UDI-Public: 40195327150571
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/15/2026

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: DYNJ49189G
• Device Lot Number: 23CMH812
• Was Device Available for Evaluation?: No
• 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: 08/08/2023
• Initial Report FDA Received Date: 09/16/2026
• 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