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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC. VANTEX-CENTRAL VENOUS CATHETER; CENTRAL LINE INSERTION BUNDLE
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EDWARDS LIFESCIENCES LLC. VANTEX-CENTRAL VENOUS CATHETER; CENTRAL LINE INSERTION BUNDLE Back to Search Results
Model Number ECVC5536
Device Problem Flushing Problem (1252)
Patient Problem No Information (3190)
Event Date 08/14/2018
Event Type  Injury  
Event Description
The ed physician inserted a central venous catheter into the pt's right groin.The distal line had blood return and flushed without difficulty.However, the medial and proximal lines would not draw blood back, but could be flushed without difficulty.The physician removed the central venous catheter and replaced with a new catheter.All lines of the new catheter had a good blood return and flushed with ease.Attempts to flush the medial and proximal lines of the central venous catheter that was removed still could not be flushed.(b)(6).
 
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Brand Name
VANTEX-CENTRAL VENOUS CATHETER
Type of Device
CENTRAL LINE INSERTION BUNDLE
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC.
MDR Report Key7826405
MDR Text Key118767314
Report NumberMW5079450
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Model NumberECVC5536
Device Lot Number2018011650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2018
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age40 YR
Patient Weight44
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