MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; COVER,LIGHT HANDLE,RIGID,(2 PER PACK)

Catalog Number	DYNJLHH2
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 1 malfunction event involving dynjlhh2.The account reported that the item was not sealed correctly and therefore was not sterile.Evaluation of five returned samples confirmed that the items were not properly sealed.Based on the complaint details, sample evaluation, and investigation, the reported issue was confirmed.No patient information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included event represents 1 malfunction event.The account reported that item dynjlhh2 was not sealed correctly and therefore was not sterile.The reported issue involved lot numbers 06924030011 and 06924050012.Five samples were returned for evaluation.Medline quality performed a visual inspection of the returned samples and confirmed that the items were not properly sealed.Finished goods production records were reviewed as part of the investigation.Based on the complaint details, sample evaluation, and investigation, the reported issue was confirmed.The vendor was notified of the issue for further evaluation, and the supplier quality team will continue to monitor this issue for trending purposes.Of the events summarized, 5 samples were returned for evaluation.Information regarding reprocessing or reuse was not identified during the investigation.

• Brand Name: MEDLINE
• Common Device Name: COVER,LIGHT HANDLE,RIGID,(2 PER PACK)
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50888574
• Report Number: 1417592-2026-50401
• Device Sequence Number: 9762049
• Product Code: FTA
• UDI-Device Identifier: 40080196761846
• UDI-Public: 40080196761846
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 5
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: DYNJLHH2
• 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: 10/09/2024
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown