MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES CANADA ULC T-DOC AIR CHARGED DUALSENSOR CATHETER; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number 7FD

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2019

Event Type  malfunction  

Event Description

Urinary catheter was inserted into patient's bladder and connected to computer via blue tooth device.Sensor readings were incorrect during calibration so catheter was replaced.The second catheter worked well.

• Brand Name: T-DOC AIR CHARGED DUALSENSOR CATHETER
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CANADA ULC; 112 corporate dr ste 12; portsmouth NH 03801
• MDR Report Key: 9219010
• MDR Text Key: 163184298
• Report Number: 9219010
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/18/2019

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 Operator: No Information
• Device Model Number: 7FD
• Device Catalogue Number: 7FD
• Device Lot Number: 181304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1