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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 FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER Back to Search Results
Catalog Number 165816
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Exposure to Body Fluids (1745)
Event Date 10/26/2023
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 foley catheter tip was leaking.The user was exposed to blood or bodily fluids and the detailed exposure was mentioned as exposed to urine.It was unknown what medical intervention was provided.
 
Event Description
It was reported that the foley catheter tip was leaking.The user was exposed to blood or bodily fluids and the detailed exposure was mentioned as exposed to urine.It was unknown what medical intervention was provided.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "inadequate material selection".The device was not returned for evaluation.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: "warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Visually inspect the product for any imperfections or surface deterioration prior to use." h11: section a through f - the information provided by bd represents all 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.H3 other text: the device was not returned.
 
Event Description
It was reported that the foley catheter tip was leaking.The user was exposed to blood or bodily fluids and the detailed exposure was mentioned as exposed to urine.It was unknown what medical intervention was provided.
 
Manufacturer Narrative
Visual: received one (1) used all-silicone foley catheter without original packaging.Visual inspection noted no obvious observations.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the catheter rested with no leaks noted.The balloon passively deflated in under one (1) minute with no cuffing or leaks noted, returning 10ml of solution.This is within specification per inspection procedure which states, catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.A review of the device history record was not necessary due to the reported event being unconfirmed.As the reported event is unconfirmed a risk and labeling review is not required.H11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.
 
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Brand Name
BARDEX® ALL-SILICONE FOLEY CATHETER
Type of Device
SILICONE FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key18158820
MDR Text Key328384665
Report Number1018233-2023-08215
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741029752
UDI-Public(01)00801741029752
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number165816
Device Lot NumberNGGU2176
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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