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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 119110
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Device Fell (4014)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2020
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 fell out.When the user inflated the catheter that had fallen out, the catheter leaked around the valve.Per additional information received on 29jul2020, water leaked from the catheter and seemed that there were no visible damage to the catheter.Catheter was replaced to the patient due to leak from the valve.
 
Manufacturer Narrative
The reported event was confirmed.Visual inspection noted one temperature sensing foley catheter was received.Visual evaluation noted no obvious defects were observed.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 from a pinhole measuring 0.012" just under the inflation cap.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure mode could be due to fixture slot to position cap out of the specification.The product was used for the treatment purposes.The product had failed to meet the specifications, and was influenced by the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was not performed due to the labeling could not have prevented the reported failure.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.
 
Event Description
It was reported that the catheter fell out.When the user inflated the catheter that had fallen out, the catheter leaked around the valve.Per additional information received on (b)(6) 2020, water leaked from the catheter and seemed that there was no visible damage to the catheter.The catheter was replaced to the patient due to a leak from the valve.
 
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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 Key10396803
MDR Text Key203464445
Report Number1018233-2020-05115
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741046001
UDI-Public(01)00801741046001
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 11/23/2020
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 Expiration Date09/30/2023
Device Model Number119110
Device Catalogue Number119110
Device Lot NumberNGCW0940
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received08/12/2020
Supplement Dates Manufacturer Received11/02/2020
Supplement Dates FDA Received11/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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