MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ACL ARTHROSCOPY PACK

Catalog Number	DYNJ82583
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the bag on the arthroscopy drape in the new acl packs separated from the drape under the thigh, leaving an approximately 6 inch break in the sterile field.".
Additional Manufacturer Narrative
The customer reported that the fluid control pouch, as part of the orthomax arthroscopy drape, came apart at glued area, and the issue was discovered during case and drape was in use.Medline reviewed finished good production records, finished good pack build, account complaint history, and component complaint history; no non-conformances were noted, there were no issues with the pack build, and no similar reported issues were identified in the past 6 months.The reported issue could not be confirmed because no sample or photo was received for the investigation.Without a sample, it is difficult to determine a true root cause, and the division will monitor for trending.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-ACL ARTHROSCOPY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50735461
• Report Number: 1417592-2026-37142
• Device Sequence Number: 10639208
• Product Code: OII
• UDI-Device Identifier: 40195327198184
• UDI-Public: 40195327198184
• 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): 09/08/2026

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: DYNJ82583
• Device Lot Number: 23IBP488
• 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: 11/21/2023
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown