• 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. PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR

  • 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. PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 0142010
Device Problem Retraction Problem (1536)
Patient Problem No Information (3190)
Event Date 02/07/2017
Event Type  malfunction  
Event Description
On de-access, the safety mechanism did not retract.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePORT ACCESS NEEDLE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key6457421
MDR Text Key71687093
Report Number6457421
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model Number0142010
Device Catalogue Number0142010
Device Lot NumberASARS0256
Other Device ID NumberPOWERLOC MAX 20G X 1 INCH
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2017
Device Age1 DY
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/04/2017 Patient Sequence Number: 1
Treatment
CHEMOTHERAPY; NO
-
-