MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MASK,FLEXIBLE,ANESTH,SIZE 6,TOP VALVE

Catalog Number	DYNJAAMASK36
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "this mask is sporadically coming in the packs defected.".
Additional Manufacturer Narrative
The customer reported defects with the masks and stated, "it¿s hit and miss, we will open a case that are all bad, then the next box will be okay." after careful examination, the investigation team determined that this is not a quality issue, there is no manufacture defect on the product or an actual issue with it.The reported problem was not confirmed, and the cause was documented as unconfirmed.This qa file will now be closed.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: MASK,FLEXIBLE,ANESTH,SIZE 6,TOP VALVE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945212
• Report Number: 1417592-2026-54038
• Device Sequence Number: 21439790
• Product Code: BSJ
• UDI-Device Identifier: 10888277399327
• UDI-Public: 10888277399327
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/29/2026

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: DYNJAAMASK36
• Device Lot Number: 49024100044
• 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: 08/13/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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