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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER; FOLEY CATHETER (LATEX)
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER; FOLEY CATHETER (LATEX) Back to Search Results
Catalog Number 129414M
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
 
Event Description
It was reported that it is difficult to deflate a balloon on the 3rd day of use.Allegedly, the water was not withdrawn when the user pulled the syringe.However, the water was removed passively when the syringe was left connected to the inflation valve for a while.
 
Event Description
It was reported that it is difficult to deflate a balloon on the 3rd day of use.Allegedly, the water was not withdrawn when the user pulled the syringe.However, the water was removed passively when the syringe was left connected to the inflation valve for a while.
 
Manufacturer Narrative
The reported event was unconfirmed since the problem could not be reproduced.The evaluation found that the returned catheter could be inflated and deflated without difficulty.There was no pinch or blockage observed on the catheter.The catheter was dissected and no conditions were found that could be associated with the reported event.Therefore, the reported event is unconfirmed based on the investigation findings.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿the device is intended for single use only and is not reusable.11) to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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Brand Name
BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
Type of Device
FOLEY CATHETER (LATEX)
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9530700
MDR Text Key178329431
Report Number1018233-2019-08324
Device Sequence Number1
Product Code MJC
Combination Product (y/n)N
PMA/PMN Number
K910318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2023
Device Catalogue Number129414M
Device Lot NumberMYDX2682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2019
Date Manufacturer Received01/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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