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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. GROSHONG CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

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BARD ACCESS SYSTEMS, INC. GROSHONG CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM Back to Search Results
Model Number 9.5 FR
Device Problems Detachment Of Device Component (1104); Connection Problem (2900)
Patient Problem No Code Available (3191)
Event Date 04/30/2016
Event Type  Injury  
Event Description
Labs were drawn from the groshong catheter. The lumen was flushed with normal saline (ns) per protocol. When starting/attaching chemo, the lumen detached completely from the line tubing. It could not be re-attached. The line was clamped and chemotherapy started on the usable side. The catheter had to be taken out and replaced surgically.
 
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Brand NameGROSHONG
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key5719692
MDR Text Key47199432
Report Number5719692
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9.5 FR
Device Catalogue Number7726950
Other Device ID NumberTUNNELED GROSHONG DOUBLE LUME
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2016
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer06/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/13/2016 Patient Sequence Number: 1
Treatment
CHEMOTHERAPY
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