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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER; TEMPERATURE SENSING CATHETER (SILICONE)

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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER; TEMPERATURE SENSING CATHETER (SILICONE) Back to Search Results
Model Number 119108
Device Problems Fluid/Blood Leak (1250); Decrease in Pressure (1490)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2020
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 the catheter was difficult to inflate due to water leakage during pretest.
 
Manufacturer Narrative
The reported event was confirmed.Visual inspection noted one temperature sensing catheter was received.Visual evaluation noted no obvious defects.Attempted to inflate the catheter's balloon with 3.5 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the solution immediately leaked out of the eyelets.The balloon was dissected to find that the inflation notch perforated both lumens.This fails to meet specifications per ip7602317 rev 19 stating "eye punching must not penetrate the inflation, irrigation lumen and/or thermistor." although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be punch depth too large.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.
 
Event Description
It was reported that the catheter was difficult to inflate due to water leakage during pretest.
 
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Brand Name
BARDEX ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
Type of Device
TEMPERATURE SENSING CATHETER (SILICONE)
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10380106
MDR Text Key202997980
Report Number1018233-2020-05048
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741045998
UDI-Public(01)00801741045998
Combination Product (y/n)N
PMA/PMN Number
K070582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 11/15/2020
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
Device Operator Health Professional
Device Model Number119108
Device Catalogue Number119108
Device Lot NumberNGDX0337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2020
Initial Date Manufacturer Received 07/16/2020
Initial Date FDA Received08/07/2020
Supplement Dates Manufacturer Received10/23/2020
Supplement Dates FDA Received11/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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