MAUDE Adverse Event Report: STERILMED, INC. ACUNAV DIAGNOSTIC ULTRASOUND; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	ACU10135936
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Faulty product, bent catheter tip noted upon opening equipment.

• Brand Name: ACUNAV DIAGNOSTIC ULTRASOUND
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway n; suite 2; plymouth MN 55446
• MDR Report Key: 12908000
• Report Number: 12908000
• Device Sequence Number: 17353480
• Product Code: OWQ
• UDI-Device Identifier: 10888551004732
• UDI-Public: (01)10888551004732(17)220511(10)2156596
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/29/2021
• Report Date (Section F): 11/29/2021

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 Model Number: ACU10135936
• Device Catalogue Number: ACU10135936
• Device Lot Number: 2156596
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White
• Date Report Sent to FDA: 11/29/2021