MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SHOULDER ARTHROSCOPY PK

Catalog Number	DYNJ81787A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pack still has excessive moisture accumulating in the pack.
Additional Manufacturer Narrative
The account reported finding pack has excessive moisture, and it was reported that there was a white, powdery residue on the sterilization pouch of a custom pack.Medline received 3 photos and a physical sample for 2 unopened packs, reviewed finished good production records, reviewed finished good pack build, and reviewed trending.The reported issue was confirmed because white powder was observed when the outside of the breather pouch was touched and the photos showed moisture build up inside of the pack.Based on the complaint details, the residue is due to "bloom," which is a normal occurrence for the pouch material caused when the additives or plasticizers in the material migrate to the surface of the film; the presence of the residue on the pouch is not harmful and does not affect the sterility of the pack or its contents.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-SHOULDER ARTHROSCOPY PK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50858565
• Report Number: 1417592-2026-48121
• Device Sequence Number: 9508738
• Product Code: OJH
• UDI-Device Identifier: 40195327532230
• UDI-Public: 40195327532230
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/22/2026

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: DYNJ81787A
• Device Lot Number: 23JBM621
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/15/2024
• 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: 01/09/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (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