• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD ACCESS SYSTEMS, INC. BARD POWERGLIDE PRO MIDLINE CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F318108PT
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
A 18g 10cm bard powerglide pro midline was placed in the patient's arm. When the rn pulled the midline device out of the patient's arm, the guidewire was not on the end of the device. It was initially thought that the guidewire may have broken off inside the patient's arm. However, a ct ruled this out. Upon inspection of the bard device it was identified that the guidewire curled up inside of the device which is not normal and identified as a defect. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD POWERGLIDE PRO MIDLINE CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
MDR Report Key11869892
MDR Text Key252616331
Report NumberMW5101491
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741140662
UDI-Public(01)00801741140662
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 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberF318108PT
Device Catalogue NumberF318108PT
Device Lot NumberREEZ3911
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? 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: 05/21/2021 Patient Sequence Number: 1
-
-