MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANEROID,HANDHELD,PREMIER,ADULT

Catalog Number	MDS9410
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: ANEROID,HANDHELD,PREMIER,ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50842004
• Report Number: 1417592-2026-46452
• Device Sequence Number: 15965209
• Product Code: DXQ
• UDI-Device Identifier: 00080196773193
• UDI-Public: 00080196773193
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211084
• 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): 09/18/2026

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: MDS9410
• Device Lot Number: 65123040002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2024
• 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: 02/21/2024
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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