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 02/04/2015

Event Type  malfunction  

Event Description

Medical specialties - broken the customer reported the nose on the valve (catheter) is damaged so it can¿t get connected with the secretion bag anymore.A valve change was made in hospital by dr.(b)(6).  neither patient injury nor medical intervention has been reported.The issue was found during a drainage by gravity procedure.Unknown if completed as planned.The patient required a the medical intervention of a valve change.

Manufacturer Narrative

(b)(4).Follow up emdr will be submitted when investigation is complete.

Manufacturer Narrative

(b)(4): the sample evaluation was able to confirm the reported failure mode.A functional test was performed and the access dilator could not be connected.The device was disassembled, and the internal blue disc was found to be dislodged and blocking the fluid pathway.A lot number was not provided with the complaint.Consequently, a device history record review could not be completed for the reported complaint.Based on the investigation results, a probable root cause from the manufacturing process could not be identified for the observed failure mode.All valve assemblies are 100% functionally leak tested prior to assembly into the pleurx catheter assembly.Any defective valve would be culled from the manufacturing process at this step and scrapped.Based on the observed defect from the complaint sample provided, the most likely source for the root cause was identified as the insertion of a foreign object into the valve causing the valve inner assembly to become dislodged.The investigation was not able to confirm this source as the root cause since the actual circumstances that contributed to the observed defect were not know by the investigation and could not be ascertained during the investigation.Based on the identified potential cause for the observed defective from the review of the complaint sample, the customer will be notified of the applicable warning contained on page 1 of the ifu regarding the use of only the access tip to access the valve.

• 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: 4717928
• MDR Text Key: 20149703
• Report Number: 1625685-2015-00177
• Device Sequence Number: 1
• Product Code: DWM
• Combination Product (y/n): N
• PMA/PMN Number: K121849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 50-7050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2015
• 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