MAUDE Adverse Event Report: CARDINAL HEALTH, INC. DOVER; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number 8887605221

Device Problems Deflation Problem (1149); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 04/21/2021

Event Type  malfunction  

Event Description

Foley catheter placed in or.Catheter flushed multiple times.Nurse went to flush catheter and catheter was dislodged and balloon was discovered to be deflated.Balloon inflated following event and no defect is apparent.

• Brand Name: DOVER
• Type of Device: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11817083
• MDR Text Key: 250371099
• Report Number: 11817083
• Device Sequence Number: 1
• Product Code: FCM
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8887605221
• Device Catalogue Number: 8887605221
• Device Lot Number: 8211150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1