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Broviac Paediatric Catheter

Notice type: Advisory

Date: 13/02/2003

  

Product name or type:
Broviac Paediatric Catheter

Reference:
SN2003(01)

Target Audience:
Department of Health & Children; Chief Executive Officers, Irish Health Boards; Chief Executive Officers, Irish Hospitals; Consultant Gastroenterologist; Nutrition Support Teams; Risk Managers; Purchasing Managers

Problem Or Issue:
The IMB has been advised of several incidents with patients on long-term total parenteral nutrition using a Broviac Paediatric Catheter.  Defects developed at a similar point on the catheter, where the hub separated from the catheter.

Background Information Or Related Documents:
Two reports of hub separation were reported to the IMB.  An investigation was carried out by the product manufacturer. The company has conducted a thorough review of the catheter.  The investigation findings confirmed the separation of the connector and the possible cause is application of excessive tensile force to the catheter assembly

Broviac Paediatric Catheter Document

Actions To Be Taken:

The IMB advise that users of this product: 

  • Ensure that all staff dealing with broviac lines are advised of the incidents that have arisen with this device.  
  • Advise all staff and family members dealing with the device to carry out regular inspections of the device.  
  • Ensure that all staff and family members are trained in the use of the catheter. Ensure the device is clamped at the points indicated by the manufacturer in their literature.  
  • Report any indication of problems with the device to the Irish Medicines Board

Further Information:
All adverse incidents relating to a Medical Device should be reported to the:   

Medical Devices Department 
Health Products Regulatory Authority
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

If you have any enquiries, you may contact the Medical Devices Department at:   

Telephone:     +353-1-6764971 
Fax:               +353-1-6767836 
Email:            vigilance@imb.ie
Website:         www.hpra.ie

SN2003(01): Broviac Paediatric Catheter

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