MAUDE Adverse Event Report: BARDVASCATHTEMPORARY IMPLANTED DIALYSIS CATH

Event Type  No Answer Provided  

Event Description

Caller concerned that vascath/permacath dialysis catheter looks too similar to regular central lines. A normal central line holds 200 u of heparin and a nurse uses this line, while a vascath/permacath dialysis line holds 1200u of heparin and is used for diaylsis only. The only staff that use this line are rns who specialize in the procedure. Other rn's who are not specialized in the usage of the lines are mistaking the dialysis cath. For the central line and utilizing it by mistake. Pts are then recieving an over bolus of heparin, which could cause a pt to "bleed out". Caller notes 2-3 incidents where this has occurred and pt's bled. Caller concerned that catheters are not labelled properly - surggests labels "for diaylsis only" or "not for i/v use" to avoid future mistakes.

• Brand Name: VASCATH
• Type of Device: TEMPORARY IMPLANTED DIALYSIS CATH
• Manufacturer (Section F): BARD; unk; unk
• Manufacturer (Section D): BARD; unk; unk
• Device Event Key: 430802
• MDR Report Key: 441828
• Event Key: 418244
• Report Number: MW1027447
• Device Sequence Number: 1
• Product Code: MSD
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/07/2003
• 2 DeviceS WERE Involved in the Event: 1 2

1 Patient Was Involved in the Event

• Date FDA Received: 02/07/2003
• Is This An Adverse Event Report?: No
• Device Operator: Invalid Data
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: Yes
• Event Location: Unknown
• Was The Report Sent To Manufacturer?: No
• Is the Device an Implant?: Yes
• Is this an Explanted Device?: No Answer Provided