MAUDE Adverse Event Report: COOK, INC. SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

Catalog Number PICS-501-MPIS

Device Problem Occlusion Within Device (1423)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 12/29/2013

Event Type  malfunction  

Event Description

A patient awaiting heart and lung transplant underwent drip via pic line.There became a complete occlusion of the line.The lot number is unknown.The device was discarded.Perfane on drip alone (highly irritating medication not compatible with perfusion tap).Day 5: abnormal increase of pressure with drip.Day 12: complete occlusion of the line.Compatibility of medication and device is dodgy.Picline still on patient.Consequences: treatment was partially stopped.Risks of infection linked to the attempts to clear for the line for a week.New line fitted.Per complaint form: "the catheter was clogged after 5 days of treatment, the nurse had changed the valve but it doesn't solve the occlusion." "the doctor had to place another catheter, but not a picc line.".

Manufacturer Narrative

(b)(4).Event is currently under investigation.

• Brand Name: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3812549
• MDR Text Key: 20458030
• Report Number: 1820334-2014-00174
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/21/2013,03/21/2014

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: Health Professional
• Device Catalogue Number: PICS-501-MPIS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/29/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/21/2014
• Initial Date FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1