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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Peritonitis (2252)

Event Date 07/07/2019

Event Type  Injury  

Event Description

Peritonitis related to pleurx drainage catheter for ascites related to alcoholic cirrhosis.Fda safety report id# (b)(4).

• Brand Name: PLEURX DRAINAGE CATHETER
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION 2200, INC.
• MDR Report Key: 8777093
• MDR Text Key: 150806421
• Report Number: MW5088001
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 72 YR
• Patient Weight: 77