MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. MEDLINE; NEEDLE, QUINCKE, 25GX3.5"

Catalog Number	PAIN8018
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: NEEDLE, QUINCKE, 25GX3.5"
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center 106; nuevo laredo 88285 ; MX 88285
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25842757
• Report Number: 1417592-2026-05838
• Device Sequence Number: 18806375
• Product Code: BSP
• UDI-Device Identifier: 10884389622278
• UDI-Public: 10884389622278
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K110194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/16/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: PAIN8018
• Device Lot Number: 25GBC541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown