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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cellulitis (1768); Death (1802); Pneumothorax (2012)

Event Date 08/27/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).If further information becomes available a follow up medwatch will be submitted.Device not returned, no lot number.

Event Description

Literature review: catheter-related complications occurred in 22 patients.The most serious complication was empyema, recorded in 10 patients (16.1%).In three of these patients, death was directly related to the empyema.Other notable complications include catheter dislodgement (n=6), pneumothorax (n=2), and cellulitis (n=1).

• Brand Name: PLEURX CATHETER
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 8974469
• MDR Text Key: 156900920
• Report Number: 1625685-2019-00104
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention