MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-OSCLJ HEAD AND NECK PACK

Catalog Number	DYNJ66509A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the back table drape has a big tear in it.
Additional Manufacturer Narrative
The customer reported that one of their techs tried to open the head & neck pack for a case and noticed that the back table drape has a big tear in it.A photo and a sample were received for investigation; the sample was of the pack insert, pouch, and back table cover, with no other pack contents received, and production records and finished good pack build were reviewed with no issues noted that would have contributed to the reported issue.The reported problem was confirmed because the back table cover had a large clean slice on it.Based on the report that the pouch was not damaged, it is likely the pack was caught and sliced during the pack assembly process; production and qc managers were notified, feedback will be provided to the build team for awareness and to prevent recurrence, 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-OSCLJ HEAD AND NECK PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: urmi parekh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50855482
• Report Number: 1417592-2026-47727
• Device Sequence Number: 15829724
• Product Code: LRO
• UDI-Device Identifier: 40193489462709
• UDI-Public: 40193489462709
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/21/2026

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: DYNJ66509A
• Device Lot Number: 22KMH484
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/12/2023
• 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: 04/06/2023
• 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