MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-EXTREMITY

Catalog Number	DYNJ80759
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the seal on the breather pouch gave way during transit.
Additional Manufacturer Narrative
The account reported finding pouch open after the seal on the breather pouch gave way during transit.A photo and a sample were received for investigation; the photo showed the top of the pouch, but the seal was not visible, and from the sample returned, the edge seam of the pouch on the tyvek end was open along the top of the bag.Based on the complaint details, photo and sample evaluation and investigation, the reported issue was confirmed.After further evaluation, it was determined that this item was pre-sealed from the component supplier, and the root cause is related to an error in the component manufacturing process; the complaint was provided to the vendor for further evaluation and supplier quality 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: DBD-EXTREMITY
• Manufacturer (Section D): Medline Industries, LP; medline industries, lp; northfield IL 60093 -275
• Manufacturer Contact: chittajallu venkata ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50715115
• Report Number: 1417592-2026-35767
• Device Sequence Number: 13408228
• Product Code: OJH
• UDI-Device Identifier: 40195327076680
• UDI-Public: 40195327076680
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/05/2026

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: DYNJ80759
• Device Lot Number: 22LBS472
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/19/2024
• 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: 04/15/2024
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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