MAUDE Adverse Event Report: COVIDIEN KENDALL PRECISION 400- FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Lot Number KM6428102

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/01/2020

Event Type  malfunction  

Event Description

Patient turned during bath and foley was found to be disconnected.Sterility of catheter no longer intact.This is a new brand of catheter currently being used.Catheter was cleaned with alcohol pads and then reconnected.Cca team was notified of issue and order to exchange foley was received at this time.

• Brand Name: KENDALL PRECISION 400- FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10884387
• MDR Text Key: 217657132
• Report Number: 10884387
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/03/2020

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 Lot Number: KM6428102
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA