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

Catalog Number	DYNJ34124J
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿they have had 6 circuits from these packs that did not pass the leak test.¿.
Additional Manufacturer Narrative
The customer reported they have had 6 circuits from these packs that did not pass the leak test.No sample or photo was received for the investigation; finished good production records were reviewed and no non-conformances were noted that would have contributed to the reported issue, and the finished good pack build was reviewed with no issues that might have an impact on the issue.Medline was not able to confirm the defect as there were no samples or detailed pictures received, and without a sample it is difficult to determine a true root cause.This complaint has been provided to the vendor for further evaluation, the supplier quality team will monitor this issue for trending purposes, and there was no report of any patient injury or adverse event.There were no reports of death, serious injury, medical intervention, or follow up care.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-LAMINECTOMY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50866686
• Report Number: 1417592-2026-48486
• Device Sequence Number: 18498127
• Product Code: OJH
• UDI-Device Identifier: 40195327522729
• UDI-Public: 40195327522729
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: DYNJ34124J
• Device Lot Number: 24AMC564
• 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: 06/25/2024
• Initial Report FDA Received Date: 09/23/2026
• 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