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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS BARD; POWERGLIDE
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BARD ACCESS BARD; POWERGLIDE Back to Search Results
Model Number 18G/8CM
Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/14/2018
Event Type  Injury  
Event Description
Rn attempted to place powerglide to right cephalic vein.The vein was accessed without difficulty, wire went in smoothly, catheter inserted halfway with resistance met at that point, withdrew device from catheter and immediately noted small wire at the tip of the device was missing.Rn immediately removed the catheter and flushed with normal saline to see if the wire was in the catheter.No wire noted.Rn advised her charge nurse and patient's nurse immediately of same.A call was placed to physician with orders received for stat chest x-ray and ultrasound of right upper extremity.X-ray and ultrasound completed with no abnormalities and no wire noted per radiologists.
 
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Brand Name
BARD
Type of Device
POWERGLIDE
Manufacturer (Section D)
BARD ACCESS
14201 lochridge blvd.
covington GA 30014
MDR Report Key7562464
MDR Text Key110027196
Report Number7562464
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 Other
Type of Report Initial
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number18G/8CM
Device Catalogue NumberF318088PT
Device Lot NumberRECP2378
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/14/2018
Event Location Hospital
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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