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

Model Number 50-7000B

Device Problems Detachment Of Device Component (1104); Connection Problem (2900)

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

Event Date 05/02/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the customer ((b)(6)) indicated that the pleural catheter was placed on (b)(6) 2014.No defect was noted in the or.The patient and the customer first noted that the cap was very difficult to replace immediately.The connection to the valve just did not seem right, and it did not click on easily.The patient has never had difficulty draining the catheter.After the valve stem came out, the patient immediately put it back in as tightly as possible and the catheter was not replaced.The patient has had no further issues but the caps remain somewhat difficult to replace.

Manufacturer Narrative

(b)(4).Results of investigation: a complaint sample was not provided for evaluation.Consequently, the quality of the product could not be evaluated.A review of applicable manufacturing, inspection, and packaging procedures did not identify any issues that may have contributed to the reported condition.Every catheter assembly is subjected to extensive functional testing and inspection during the assembly process to verify performance and conformity to engineering design.Likewise, a review of all manufacturing methods and personnel involved in the assembly of the device determined there was no contribution from either to the reported condition.A review of the internal production records for the lot involved could not be performed as lot number information was not available.Based on the investigation results, a definitive root cause could not be identified as the sample was not available for analysis.Although the reported condition could not be confirmed and the most root cause could not be determined without a sample being provided, the manufacturing plant will continue to monitor this issue to identify the need for any actions.

Event Description

The customer reported the valve became detached from the catheter because the patient was trying so hard to get the cap to connect properly.The customer states that prior to the name being printed on the valve, they were fine, but since then the pleurx valve caps are hard to get on the valve.

Manufacturer Narrative

(b)(4).Additional information has been requested but not yet received.If additional information and/or the sample is made available, a follow-up medwatch will be submitted.

• Brand Name: PLEURX PLEURAL CATHETER 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 OK 74044
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3841402
• MDR Text Key: 4555988
• Report Number: 1625685-2014-00123
• Device Sequence Number: 1
• Product Code: DWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 50-7000B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2014
• 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