MAUDE Adverse Event Report: COOK MEDICAL INC FUHRMAN PLEURA PNEUMOCARDIAL DRAINAGE SET; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number G55723 C-PPD-850-IMH

Device Problems Crack (1135); Shelf Life Exceeded (1567)

Patient Problem Pneumothorax (2012)

Event Date 07/10/2015

Event Type  malfunction  

Event Description

An 8.5 pigtail ct was inserted, initially appeared to functioning properly but soon there were indications it was not.Post- procedure cxr showed large pneumothorax and radiologist noted the device appeared cracked within patient.Patient had to go to or for removal.It was discovered the device expired 2/2015 but it was unclear the role this may have played in the event.

• Brand Name: FUHRMAN PLEURA PNEUMOCARDIAL DRAINAGE SET
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK MEDICAL INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 4972774
• MDR Text Key: 6077261
• Report Number: 4972774
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/14/2015

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: Invalid Data
• Device Catalogue Number: G55723 C-PPD-850-IMH
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR