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 DUO W/9.5FR GROSH D/L ATT PA; 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 DUO W/9.5FR GROSH D/L ATT PA; IMPLANTABLE PORT Back to Search Results
Model Number 0607650
Medical Device Problem Code Obstruction of Flow (2423)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A lot history review could not be performed as the lot number was not provided.The sample was not returned for evaluation, therefore, the investigation is inconclusive for the alleged obstruction of flow issue.The root cause cannot be determined at this time.The device was labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of reported information indicates that model 0607650, implantable port, allegedly experienced an obstruction of flow.This information was received from a single source.This malfunction involved a female patient with no consequences.The patient's age and weight were not provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
XPORT DUO W/9.5FR GROSH D/L ATT PA
Common Device Name
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9960427
Report Number3006260740-2020-01288
Device Sequence Number2377788
Product Code LJT
UDI-Device Identifier00801741026225
UDI-Public(01)00801741026225
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) 04/14/2020
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 Number0607650
Device Catalogue Number0607650
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2020
Initial Report FDA Received Date04/14/2020
Patient Sequence Number1
-
-