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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; SILICONE CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER; SILICONE CATHETER Back to Search Results
Catalog Number 165816
Device Problems Difficult to Remove (1528); Material Deformation (2976)
Patient Problem Pain (1994)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
 
Event Description
It was reported that upon removal of the catheter the balloon formed a mushroom.The complainant alleged that the mushroomed balloon made it difficult to remove the catheter.Allegedly the catheter was removed through pulling and cause the patient some pain.No patient injury was reported.
 
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 upon removal of the catheter the balloon formed a mushroom.The complainant alleged that the mushroomed balloon made it difficult to remove the catheter.Allegedly the catheter was removed through pulling and cause the patient some pain.No patient injury was reported.
 
Manufacturer Narrative
The reported issue (it was reported that the catheter balloon formed a mushroom upon removal from patient.Complainant alleges that mushroomed balloon made it difficult to remove catheter.Allegedly the catheter was removed through pulling and cause the patient some pain.No patient injury was reported) was confirmed, as cause unknown.Per visual inspection cuffing was noted on the catheter.Per functional evaluation the balloon was inflated with air and deflated, a cuff roll was not formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe the catheter was left for 3 minutes resting in a flat surface.Then it was deflated by itself and a cuff roll was formed.Dimensional evaluation of the catheter was found within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿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.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
 
Event Description
It was reported that upon removal of the catheter the balloon formed a mushroom.The complainant alleged that the mushroomed balloon made it difficult to remove the catheter.Allegedly, the catheter was removed through pulling and caused the patient some pain.No patient injury was reported.
 
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Brand Name
BARDEX® ALL-SILICONE FOLEY CATHETER
Type of Device
SILICONE CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7063975
MDR Text Key93755177
Report Number1018233-2017-06134
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2022
Device Catalogue Number165816
Device Lot NumberNGBQ2738
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received01/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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