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 PERIPHERAL VASCULAR, INC. CARBOFLO VASCULAR GRAFT
  • 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 PERIPHERAL VASCULAR, INC. CARBOFLO VASCULAR GRAFT Back to Search Results
Model Number 10S05TWC
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided; therefore, a lot history review is currently being performed.The device was not returned to the manufacturer for evaluation.The investigation is therefore inconclusive due to no sample return.Based on the available information, the definitive root cause could not be determined.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 10s05twc vascular graft allegedly experienced device contamination with chemical or other material.This information was received from one source.There was no patient involved as there was no patient contact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CARBOFLO VASCULAR GRAFT
Common Device Name
VASCULAR GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key9979690
Report Number2020394-2020-03078
Device Sequence Number13975496
Product Code DSY
UDI-Device Identifier00801741021107
UDI-Public(01)00801741021107
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) 04/20/2020
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 Number10S05TWC
Device Catalogue Number10S05TWC
Device Lot NumberVTDV0526
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2020
Initial Report FDA Received Date04/20/2020
Patient Sequence Number1
-
-