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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD POWERGLIDE PRO 18G MIDLINE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BARD POWERGLIDE PRO 18G MIDLINE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number REEU2440
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 08/11/2021
Event Type  malfunction  
Event Description
Bard midline 18g powerglide pro, blunt end, 2 failed attempts due to defect of blunt tip to catheter. Successful 3rd attempt. Fda safety report id# (b)(4).
 
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Brand NameBARD POWERGLIDE PRO 18G MIDLINE
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12331636
MDR Text Key267079990
Report NumberMW5103282
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 08/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberREEU2440
Was Device Available for Evaluation? Yes
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

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