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U.S. Department of Health and Human Services

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

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BARD POWERGLIDE PRO MIDLINE CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number F120080T
Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 08/24/2021
Event Type  Injury  
Event Description
When iv team attempted to place new midline, they felt as though the device was not "threading properly", so they removed it in the process of withdrawing the midline they found that part of the device came off and likely became lodged in the patient's left forearm. Xray obtained showed a 13 mm long catheter fragment visible in the superficial subcutaneous fat of the mid right forearm anterolaterally. A (b)(6) presents to the ob emergency dept at 37 weeks and 3 days with complaints of possible leakage fluid, contractions, concerns abut her midline. 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
MDR Report Key12384946
MDR Text Key268991049
Report NumberMW5103572
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberF120080T
Device Lot NumberREFQ4659
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

Patient Treatment Data
Date Received: 08/27/2021 Patient Sequence Number: 1
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