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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED
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C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED Back to Search Results
Catalog Number 123514A
Device Problem Use of Device Problem (1670)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/26/2023
Event Type  Injury  
Event Description
It was reported that the foley catheter broken and partially left behind in patient.It was stated that on september 26, a patient in the ccu pulled out his bladder catheter themself in a confused state.The part of the bladder catheter had broken off and had therefore remained in the patient's urethra or bladder (approximately 8-12 cm).It was unknown what medical intervention was provided.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Manufacturer Narrative
The reported event was confirmed ¿ user related.The reported failure was able to be reproduced.The product was used for urological care.The product had caused the reported failure.Based on photo provided, it was observed the catheter was cut off at the shaft.Based on entry description, the breakage was broken due to patient¿s pull the catheter.The potential root cause for this failure mode could be user related since the patient had pulled the catheter.The lot number is unknown; therefore, the device history record could not be reviewed.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 latex.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.For urological use only.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." 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.
 
Event Description
It was reported that the foley catheter broken and partially left behind in patient.It was stated that on september 26, a patient in the ccu pulled out his bladder catheter themself in a confused state.The part of the bladder catheter had broken off and had therefore remained in the patient's urethra or bladder (approximately 8-12 cm).It was unknown what medical intervention was provided.
 
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Brand Name
BARDIA® FOLEY CATHETER SILICONE COATED
Type of Device
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 Key18099930
MDR Text Key327707158
Report Number1018233-2023-07975
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K910846
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
Report Date 11/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number123514A
Device Lot NumberMYHQ2723
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2023
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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