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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 22G 8CM CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS, INC. BARD POWERGLIDE PRO MIDLINE CATHETER 22G 8CM CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number REFP4313
Device Problem Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 10/18/2021
Event Type  Injury  
Event Description
Rn placing midline in patient, line in vein, she then advanced guide-wire, then attempted to advance catheter. Catheter would not advance, rn noted that plastic piece at end of catheter had separated pulling the catheter off the track. Had to remove catheter, guide-wire and needle. Patient required another insertion with different device. Fda safety report id# (b)(4).
 
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Brand NameBARD POWERGLIDE PRO MIDLINE CATHETER 22G 8CM
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
MDR Report Key12681578
MDR Text Key278159296
Report NumberMW5104839
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberREFP4313
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/21/2021 Patient Sequence Number: 1
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