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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; BARDIA FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED; BARDIA FOLEY CATHETER Back to Search Results
Catalog Number 123518A
Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed the device was not returned.
 
Event Description
It was reported that the patient underwent a cystoscopy on (b)(6) 2019 at 12:00 am.After the operation, a urinary catheter was indwelled to drain urine.On (b)(6) 2019 at 3:00 am, the catheter detached by itself after the balloon ruptured.The patient complained of no discomfort.This was reported to the surgeon who re-indwelled catheter.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential root cause for this failure mode could be user related (example: contact with sharp object)/ / exposure to petrolatum based products mechanical failure/operator error.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: ¿scope of application: disposable sterile catheter for children and adults to discharge urine from the bladder.Note: this product contains natural latex that may cause an allergic reaction.Sterility is guaranteed only when the package is not opened or has not been damaged.Warning: do not use ointments or lubricants containing vaseline ingredients.These products will damage the latex and may cause the balloon to burst.It is forbidden to pump urine through the wall of the urination funnel.Single use only.Repeat sterilization is prohibited.For urinary use only.Please check the product for incompleteness or surface wear before use.Type of valve: inline syringe.Do not use the needle.The correct way to shrink the balloon: gently insert the syringe into the valve of the catheter.Do not use excessive force when the syringe is ¿pierced¿ into the valve.If the contraction is found to be slow or not at all, the syringe should be gently reset.If necessary, the balloon can only be contracted by gentle suction.Forced suction may cause the inflation lumen to collapse.If the hospital's operating specifications permit, the valve can be shut off.If the operation fails, the professional who has received sufficient training should be consulted in accordance with the relevant regulations of the hospital's operating regulations.Once the balloon has ruptured, care should be taken to ensure that all balloon fragments are removed from the patient.Storage: the catheter should be stored at room temperature and away from direct sunlight, preferably in the original box.Note: (us) federal law restricts the device to be sold or ordered only by a physician." 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 patient underwent a cystoscopy on (b)(6) 2019 at 12:00 am.After the operation, a urinary catheter was indwelled to drain urine.On (b)(6) 2019 at 3:00 am, the catheter detached by itself after the balloon ruptured.The patient complained of no discomfort.This was reported to the surgeon who reinstalled catheter.
 
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Brand Name
BARDIA® FOLEY CATHETER SILICONE COATED
Type of Device
BARDIA FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8865256
MDR Text Key153669369
Report Number1018233-2019-04506
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/28/2022
Device Catalogue Number123518A
Device Lot NumberMYCNRA42
Was Device Available for Evaluation? No
Date Manufacturer Received08/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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