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

Model Number 50-7500B

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

Patient Problem Pleural Effusion (2010)

Event Date 05/08/2017

Event Type  malfunction  

Event Description

A 500ml bottle.Immediate sound and feel of air escaping from half-moon cap when roller clamp was opened by nurse.Roller clamp was confirmed to be tightly closed before puncturing cap.Second bottle was used from same 14 count multi box without problem.The bottles appeared normal.I would set it up, attach the bottle and get one little squirt.I knew pt had fluid in there because of lung sounds and history.I would open up another bottle and get out 800 or so mls.

• Brand Name: PLEURX
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION 2200, INC; 400 east foster rd.; mannford OK 74044
• MDR Report Key: 6617997
• MDR Text Key: 76846727
• Report Number: 6617997
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/29/2019
• Device Model Number: 50-7500B
• Device Lot Number: 0001035350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2017
• Device Age: 1 DY
• Event Location: Home
• Date Report to Manufacturer: 05/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1