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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERGLIDE PRO MIDLINE CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BARD ACCESS SYSTEMS, INC. POWERGLIDE PRO MIDLINE CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F118100
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2020
Event Type  malfunction  
Event Description
Registered nurse (rn) trained in ultrasound guided iv placement was preparing to place an ultrasound guided powerglide midline.Rn reported that prior to placement, the rn checked the guidewire and noted it would not deploy.The rn attempted to loosen the guidewire by moving the "purple slide" up/down but the wire would not deploy.This device was removed, and a new catheter was obtained.
 
Event Description
Registered nurse (rn) trained in ultrasound guided iv placement was preparing to place an ultrasound guided powerglide midline.Rn reported that prior to placement, the rn checked the guidewire and noted it would not deploy.The rn attempted to loosen the guidewire by moving the "purple slide" up/down but the wire would not deploy.This device was removed, and a new catheter was obtained.
 
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Brand Name
POWERGLIDE PRO MIDLINE CATHETER
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key10400902
MDR Text Key202704828
Report Number10400902
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberF118100
Device Catalogue NumberF118100
Device Lot NumberREEN2159
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2020
Event Location Hospital
Date Report to Manufacturer08/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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