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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BROVIAC; CATHETER, INTRAVASCULAR, THERAPUETIC
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BARD ACCESS SYSTEMS, INC. BROVIAC; CATHETER, INTRAVASCULAR, THERAPUETIC Back to Search Results
Catalog Number 0600044
Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Improper Flow or Infusion (2954); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2016
Event Type  malfunction  
Event Description
Baby born with complications from exposure to mother's use of iv heroin, methadone and no prenatal care.The broviac catheter placed into left groin vein for administration of tpn/lipids secondary to feeding intolerance.Approximately four weeks later the patient's rn called cn to help evaluate broviac due to difficulty getting blood return.Removed dressing to see line and upon straightening, blood return improved and line was flushed without difficulty.The dressing was reapplied.Tpn and lipids connected and upon starting blood was seen backing up in line.As the dressing was being removed, a pop was heard and saline, tpn, and blood splattered.The broviac had a visible hole in line.The line was removed and a new 4.2 fr broviac was placed.
 
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Brand Name
BROVIAC
Type of Device
CATHETER, INTRAVASCULAR, THERAPUETIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key6213435
MDR Text Key63558018
Report Number6213435
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Catalogue Number0600044
Device Lot NumberREZB0306
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/12/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer12/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO; NO OTHER THERAPIES
Patient Weight4
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