Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 XPORT ISP MRI 6FR CFLEX W/ INTER KIT; IMPLANTABLE PORT
  • 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 XPORT ISP MRI 6FR CFLEX W/ INTER KIT; IMPLANTABLE PORT Back to Search Results
Model Number 0607530
Medical Device Problem Codes Defective Component (2292); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned to bd for evaluation.Electronic photos were provided and reviewed.The investigation is confirmed for a defective component and component caught in seal.Based on the information provided, the definitive root cause is unknown.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0607530 implanted port allegedly experienced a defective component and component caught in seal.This information was received from one source.This malfunction did not involved a patient with patient status unknown.The patient age, gender, and weight were not provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
XPORT ISP MRI 6FR CFLEX W/ INTER KIT
Common Device Name
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9209390
Report Number3006260740-2019-03154
Device Sequence Number305136
Product Code LJT
UDI-Device Identifier00801741026171
UDI-Public(01)00801741026171
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number0607530
Device Catalogue Number0607530
Device Lot NumberRECW1734
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2019
Initial Report FDA Received Date10/18/2019
Patient Sequence Number1
-
-