MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES CORP AIR-CHARGED SINGLE SENSOR CATHETER; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number CAT895

Device Problems Gas/Air Leak (2946); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

This is a specialty catheter we use in our urodynamics room.The type of catheter is an outside order called an air-charged single sensor catheter that is ordered from laborie medical technologies canada ulc.The catheter was placed into the patients urethra and then we noticed that no urine was coming out, just air.Upon further inspection, the catheter had been shredded at the y-site where the catheter meets the portion that hooks to the computer.

• Brand Name: AIR-CHARGED SINGLE SENSOR CATHETER
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CORP; 180 international drive; portsmouth NH 03801
• MDR Report Key: 17078235
• MDR Text Key: 316682452
• Report Number: 17078235
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CAT895
• Device Lot Number: 221842
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Sex: Female
• Patient Weight: 11 KG