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

Catalog Number 50-9050

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

When disconnecting the pleurx drain the white valve came away from the catheter.Causing the fluid to leak from the catheter.(b)(6) grabbed the white valve and put it back on the catheter and was able to continue to drain the patient.Pt was referred back to (b)(6) interventional radiology to have catheter replaced.The dr at (b)(6) said that it was draining just fine and that there was no need to replace catheter.So patient was sent home and continues to be drained approx every second day.Nurse contacted me because she is concerned that the valve may fall out again.

Event Description

When disconnecting the pleurx drain the white valve came away from the catheter.Causing the fluid to leak from the catheter.(b)(6) grabbed the white valve and put it back on the catheter and was able to continue to drain the patient.Pt was referred back to (b)(6) radiology to have catheter replaced.The dr at (b)(6) said that it was draining just fine and that there was no need to replace catheter.So patient was sent home and continues to be drained approx every second day.Nurse contacted me because she is concerned that the valve may fall out again.

• Brand Name: PLEURX PERITONEAL CATHETER MINI KIT
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7842457
• MDR Text Key: 119499977
• Report Number: 1625685-2018-00040
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• PMA/PMN Number: K160437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-9050
• Device Lot Number: 0001160341
• Date Manufacturer Received: 08/17/2018
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other