MAUDE Adverse Event Report: CAREFUSION PLEURX PLEURAL CATHETER MINI KIT; APPARATUS, SUCTION, PATIENT CARE

Model Number 50-7050

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

The nose on the valve (catheter) was aborted.So it couldn¿t be connected with the secretion bag anymore.A valve change will be made in hospital. neither patient injury nor medical intervention has been reported.

Manufacturer Narrative

(b)(4).If furthur information becomes available a follow up med watch will be submitted.

• Brand Name: PLEURX PLEURAL CATHETER MINI KIT
• Type of Device: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 400 east foster rd; mannford 74044
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4386981
• MDR Text Key: 5364538
• Report Number: 1625685-2015-00143
• Device Sequence Number: 1
• Product Code: DWM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 50-7050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR