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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEM ACCUCATH INTRAVENOUS CATHETER SYSTEM; CATHETER, INTRAVASCULAR
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BARD ACCESS SYSTEM ACCUCATH INTRAVENOUS CATHETER SYSTEM; CATHETER, INTRAVASCULAR Back to Search Results
Model Number 20.6./2.25
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Sticking (1597)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/15/2018
Event Type  Injury  
Event Description
Patient was undergoing an insertion of a peripheral vascular access device using ultrasound.Accucath was inserted and wire advanced without difficulty in right cephalic vein with good blood return noted.During retraction of wire the wire got "hung up" and the practitioner attempted to pull back on the catheter.The needle tip caught the end of the catheter resulting ina shearing off of tip of catheter.On (b)(6) 2018, the iv catheter tip was surgically removed and patient tolerated procedure without complications noted.
 
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Brand Name
ACCUCATH INTRAVENOUS CATHETER SYSTEM
Type of Device
CATHETER, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEM
salt lake city UT 84116
MDR Report Key7540426
MDR Text Key109303910
Report NumberMW5077427
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 Other Health Care Professional
Type of Report Initial
Report Date 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2020
Device Model Number20.6./2.25
Device Lot NumberRECN0849
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/23/2018
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 Age42 YR
Patient Weight78
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