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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER Back to Search Results
Catalog Number 0165L18
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2023
Event Type  malfunction  
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.H3 other text : the device was not returned.
 
Event Description
It was reported that the emergency care who was having issues with this catheter.The catheter was blocked and the lumen for the inflow/outflow did not work properly.On (b)(6) 2023, a patient came to emergency room using the bladder catheter.This bladder catheter had become clogged and also, the lumen for inflow and outflow of the balloon was defective.With bladder irrigation only inflow was possible, outflow was not possible.Also, balloon contents cannot be drained, it immediately vacuums, with difficulty 2cc extraction.Finally together with doctor laboriously able to drain 5cc balloon contents, turned out to be full contents.Cad removed and new one placed.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be user related (example: salt accumulation)/block drainage lumen/no drainage eye).The device was not returned for evaluation.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 device was not returned.
 
Event Description
It was reported that the emergency care who was having issues with this catheter.The catheter was blocked and the lumen for the inflow/outflow did not work properly.On (b)(6) 2023, a patient came to emergency room using the bladder catheter.This bladder catheter had become clogged and also, the lumen for inflow and outflow of the balloon was defective.With bladder irrigation only inflow was possible, outflow was not possible.Also, balloon contents cannot be drained, it immediately vacuums, with difficulty 2cc extraction.Finally together with doctor laboriously able to drain 5cc balloon contents, turned out to be full contents.Cad removed and new one placed.
 
Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.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: "sterile: unless package has been opened or damaged.Warning: do not use ointments or lubricants having a petroleum base.They will damage latex and may burst balloon.Do not aspirate urine through the drainage funnel wall.Single use only.Do not reserialize.For urological use only.Valve type: use luer slip syringe.Don not use needle.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.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 permitted by hospital protocol, the valve arm may be severed.If this fails, contact an adequately trained professional for assistance, as directed by hospital protocol." 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 emergency care who was having issues with this catheter.The catheter was blocked and the lumen for the inflow/outflow did not work properly.On (b)(6) 2023, a patient came to emergency room using the bladder catheter.This bladder catheter had become clogged and also, the lumen for inflow and outflow of the balloon was defective.With bladder irrigation only inflow was possible, outflow was not possible.Also, balloon contents cannot be drained, it immediately vacuums, with difficulty 2cc extraction.Finally together with doctor laboriously able to drain 5cc balloon contents, turned out to be full contents.Cad removed and new one placed.
 
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Brand Name
BARDEX® LUBRICATH® FOLEY CATHETER
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 Key16794963
MDR Text Key313817400
Report Number1018233-2023-02804
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,Followup
Report Date 06/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0165L18
Device Lot NumberMYFY3346
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2022
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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