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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWERGLIDE PRO MIDLINE CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS, INC. BARD POWERGLIDE PRO MIDLINE CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 20G X 10CM
Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/16/2021
Event Type  Injury  
Event Description
Nurse used ultrasound guide for r basilic vein, visual placement of tip in vessel, flash noted, guide wire advanced without resistance. Nurse advanced catheter and met resistance and noted bulging in the tissue. Turniquet remove, device withdrawn. Nurse assess catheter tip and noted tip of catheter to be missing. Xray ordered. Tip of catheter remains in patient. Patient will need to go for foreign body removal. Fda safety report id# (b)(4).
 
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Brand NameBARD POWERGLIDE PRO MIDLINE CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
MDR Report Key12861701
MDR Text Key281215094
Report NumberMW5105525
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
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20G X 10CM
Device Catalogue NumberF320108PT
Device Lot NumberREFU2949
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/22/2021 Patient Sequence Number: 1
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