• 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. POWER LOC MAX 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. POWER LOC MAX SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 0141975
Device Problems Disconnection (1171); Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2018
Event Type  malfunction  
Event Description
While attempting to disconnect powerloc from the patient's port site, the powerloc would not disengage from the port. The powerloc was directly pulled out of port site but unable to retract the needle.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOWER LOC MAX
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key7227276
MDR Text Key98545317
Report Number7227276
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 01/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2020
Device Catalogue Number0141975
Device Lot NumberASBXS0052
Other Device ID Number0743014 1605R
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/17/2018
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

-
-