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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. ACCUCATH INTRAVASCULAR CATHETER 18G CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS, INC. ACCUCATH INTRAVASCULAR CATHETER 18G CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 18GX2.25IN
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/10/2019
Event Type  Injury  
Event Description
The catheter completely dislodged from the hub and remained in the pt's upper arm. Ultrasound scan did not pick up the dislodged catheter in the pt therefore the opacity of the catheter is questionable. The catheter had to be surgically removed. Fda safety report id# (b)(4).
 
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Brand NameACCUCATH INTRAVASCULAR CATHETER 18G
Type of DeviceCATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
salt lake city UT 84116
MDR Report Key8615644
MDR Text Key145373483
Report NumberMW5086672
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 Risk Manager
Type of Report Initial
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number18GX2.25IN
Device Catalogue NumberACO182250
Device Lot NumberRECU0738
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/15/2019 Patient Sequence Number: 1
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