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: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH TEMPERATURE SENSING FOLEY CATHETER
  • 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
 

C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH TEMPERATURE SENSING FOLEY CATHETER Back to Search Results
Model Number A119416M
Medical Device Problem Code Erratic or Intermittent Display (1182)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/05/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event or Problem Description
It was reported that temperature sensing foley catheter was reading too high.When the esophageal probe was placed, foley remained high when compared to esophageal.Calibration of the philips monitor was checked by their biomed and found to be correct.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BARDEX LUBRICATH TEMPERATURE SENSING FOLEY CATHETER
Common Device Name
TEMPERATURE SENSING FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key12401602
Report Number1018233-2021-05318
Device Sequence Number4030307
Product Code EZC
UDI-Device Identifier00801741073700
UDI-Public(01)00801741073700
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K910846
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/09/2021
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 Health Professional
Device Model NumberA119416M
Device Catalogue Number119416M
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/05/2021
Initial Report FDA Received Date08/31/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-