• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARDVASCATHTEMPORARY IMPLANTED DIALYSIS CATH

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD VASCATH TEMPORARY IMPLANTED DIALYSIS CATH   Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVASCATH
Type of DeviceTEMPORARY IMPLANTED DIALYSIS CATH
Manufacturer (Section F)
BARD
unk
unk
Manufacturer (Section D)
BARD
unk
unk
Device Event Key430802
MDR Report Key441828
Event Key418244
Report NumberMW1027447
Device Sequence Number1
Product CodeMSD
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 Received02/07/2003
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

-
-