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

MAUDE Adverse Event Report: BARD MEDICAL DIVISION BARD POWER LOC SAFETY INFUSION SET

  • 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 MEDICAL DIVISION BARD POWER LOC SAFETY INFUSION SET Back to Search Results
Model Number 0672234
Device Problems Bent (1059); Difficult to Advance (2920)
Patient Problem No Information (3190)
Event Date 10/23/2017
Event Type  Injury  
Event Description
Unable to access pt with power port needle. Upon puncturing skin, noted needle to bend. Unable to lower needle into position.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD
Type of DevicePOWER LOC SAFETY INFUSION SET
Manufacturer (Section D)
BARD MEDICAL DIVISION
covington GA 30014
MDR Report Key6989941
MDR Text Key90767968
Report NumberMW5073044
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2019
Device Model Number0672234
Device Lot NumberASBRS0128
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: 10/31/2017 Patient Sequence Number: 1
-
-