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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PERIPHERAL CATHETER INSERTION KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS, INC. PERIPHERAL CATHETER INSERTION KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F220108PT
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/04/2021
Event Type  malfunction  
Event Description
While placing a 10 cm 20gu powerglide pro midline into patient's left basilic vein, upon retraction of guidewire, the 20 gu catheter sheared off leaving approx. 7 cm of catheter inside patient¿s vessel. Piece of catheter visible in vessel under ultrasound. Soft tourniquet applied above puncture site; primary provider and ir notified. Vascular surgery notified. Patient transferred to another campus for surgical intervention to remove piece of catheter.
 
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Brand NamePERIPHERAL CATHETER INSERTION KIT
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 Key12664505
MDR Text Key277397339
Report Number12664505
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF220108PT
Device Catalogue NumberF220108PT
Device Lot NumberREFT2323
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/05/2021
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer10/20/2021
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 Unkown

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