MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number NOT AVAILABLE-ITEM DISCARDED

Device Problems Material Rupture (1546); Device Slipped (1584); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2020

Event Type  malfunction  

Event Description

14fr foley catheter from the gyno laparoscopy pack was placed with no issues and mid case the foley came out and the balloon was noted to be popped (there was a clean cut line on the side of the balloon) there was no damage to the bladder and no energy or sharp instruments came in contact with the balloon.Foley was replaced.

• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 10704744
• MDR Text Key: 212090012
• Report Number: 10704744
• Device Sequence Number: 1
• Product Code: DQO
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NOT AVAILABLE-ITEM DISCARDED
• Device Lot Number: NOT AVAILABLE-ITEM DISCARDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA