MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV BIO-MEDICUS NG ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	96570-119
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2026
Type of Reportable Event	Malfunction

• Brand Name: BIO-MEDICUS NG ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50834799
• Report Number: 9617601-2026-05705
• Device Sequence Number: 10278652
• Product Code: DWF
• UDI-Device Identifier: 00763000116095
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2026

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 Model Number: 96570-119
• Device Catalogue Number: 96570-119
• Device Lot Number: 230420808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/20/2026
• Date Device Manufactured: 01/10/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown