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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. GROSHONG 9.5 F DUAL-LUMEN CV CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS, INC. GROSHONG 9.5 F DUAL-LUMEN CV CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 7726950 LOG59809
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2017
Event Type  malfunction  
Event Description
Patient has had a groshong catheter inserted and the original red port fell off 10 days later. Patient called the rn into the room to report the red port fell off, nothing was infusing at the time.
 
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Brand NameGROSHONG 9.5 F DUAL-LUMEN CV CATHETER
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key6791154
MDR Text Key82577423
Report Number6791154
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 08/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7726950 LOG59809
Device Lot NumberREBQ1592
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/09/2017
Event Location Other
Date Report to Manufacturer08/09/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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