MAUDE Adverse Event Report: CAREFUSION 2200, INC PLEURX; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number 50-7510

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2021

Event Type  malfunction  

Event Description

Rn attempted to drain pleurx out of patient.The rn connected the bulb suction to patient and pressed down to create vacuum and unreleased the roller clap.About 2-10ml into drainage, the clear tubing that is attached to top of bulb canister became disconnected from the plastic piece you push down on.

• Brand Name: PLEURX
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 11321114
• MDR Text Key: 231609462
• Report Number: 11321114
• Device Sequence Number: 1
• Product Code: PNG
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-7510
• Device Lot Number: 0001380259
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA