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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERGLIDE PRO; 22G MIDELINE CATHETER
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BARD ACCESS SYSTEMS, INC. POWERGLIDE PRO; 22G MIDELINE CATHETER Back to Search Results
Model Number F122080
Device Problems Bent (1059); Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/01/2017
Event Type  Injury  
Event Description
Upon disengagement of the powerglide pro midline, iv team rn was unable to remove the guidewire from the patient's right arm.Entire midline catheter was left in patient's arm, covered with sterile 4x4 and wrapped lightly with coflex to ensure no movement of catheter.Md notified.Patient taken to interventional radiology.On exam, the md noted the needle partly out and the outer plastic cannula crumpled and mostly inside the skin.Under fluoroscopic guidance, gentle traction was given to the needle and the crumpled intact cannula was successfully removed with a hemostat.Fluoroscopic images showed no retained radiopaque foreign body in the mid arm.Patient tolerated the procedure well.
 
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Brand Name
POWERGLIDE PRO
Type of Device
22G MIDELINE CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
salt lake city UT 84116
MDR Report Key6390792
MDR Text Key69569706
Report NumberMW5068346
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/08/2018
Device Model NumberF122080
Device Lot NumberREAW0232
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/07/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age31 YR
Patient Weight55
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