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U.S. Department of Health and Human Services

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

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BARD, INC POWERGLIDE® MIDLINE CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number POWERGLIDE® MIDLINE CATHETER
Device Problems Bent (1059); Detachment Of Device Component (1104); Component Missing (2306)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 08/25/2017
Event Type  malfunction  
Event Description
Vat nurse called to evaluate patient for iv access. Upon inserting a power glide, this nurse noted something firm with insertion. A bend in the catheter was noted with ultrasound evaluation and the catheter was withdrawn. With further evaluation, it was seen that there was a small piece of catheter remaining in the vein upon ultrasound and the piece missing from the top of the catheter. Dr. Was notified and the patient sent to ir for retrieval. Patient was educated regarding the situation and process.
 
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Brand NamePOWERGLIDE® MIDLINE CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD, INC
605 north 5600 west
salt lake city UT 84116
MDR Report Key6935421
MDR Text Key88824357
Report Number6935421
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPOWERGLIDE® MIDLINE CATHETER
Device Catalogue NumberNOT KNOWN
Device Lot NumberNOT KNOWN
Other Device ID Number10CM
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/11/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer09/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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