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

Model Number 50-7000B

Device Problems Component Missing (2306); Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon carefusions investigation a follow up emdr will be submitted.

Event Description

Customer stated via email: valve missing from catheter.This pleurx was placed last week, the pa said that they never had a good connection and were taping it.The pa came in today ((b)(6) 2015) to disconnect from atrium and noticed it didn't have a valve.The pa said they never had a good connection (like they normally do) from the or when they connected it to an atrium.They had it taped for 36 (ish) hours.The same pa was disconnecting the atrium to start to prepare the patient being transferred to (b)(6) hospital.Patient is only (b)(6).

Manufacturer Narrative

(b)(4).A complaint sample was not provided for evaluation.Consequently, the quality of the product could not be evaluated in regards to the reported failure mode.Since returned sample lot number was not provided, dhr review was not performed.(b)(4).Without the missing components, it cannot be fully determined what caused the failure in the field.It is hypothesized there was either misuse with the lockable access tip (part of the lockable drainage line), a molding error in the valve top or assembly error.Since no probable root cause was identified for this failure mode, the investigation was not able to identify a corrective or preventive action for the reported failure.This defect will be entered into the complaint system and will be tracked/trended for future occurrences.

• 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 74044
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5128483
• MDR Text Key: 27861749
• Report Number: 1625685-2015-00218
• 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
• Reporter Occupation: Physician Assistant
• Type of Report: Followup
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician Assistant
• Device Model Number: 50-7000B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2015
• 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
• Patient Age: 20 YR