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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE)
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE) Back to Search Results
Catalog Number 1758SI16
Device Problems Calcified (1077); Deflation Problem (1149); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2017
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 the user was unable to deflate the balloon of the catheter.This event occurred on the 3rd day of usage and calcification on the tip of the catheter was confirmed.The user said that he/she felt tactile resistance as he/she withdrew the water of the balloon with a syringe.The user attempted to pump and the catheter could be removed from the patient successfully after 0.6 ml of water was withdrawn.No bleeding and no urethra damage was reported.
 
Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection noted there appeared to be calcification at the tip and drainage eyes.No manufacturing defects were observed.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: ¿warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage silicone.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize 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.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
 
Event Description
It was reported that the user was unable to deflate the balloon of the catheter.This event occurred on the 3rd day of usage and calcification on the tip of the catheter was confirmed.The user said that he/she felt tactile resistance as he/she withdrew the water of the balloon with a syringe.The user attempted to pump and the catheter could be removed from the patient successfully after 0.6 ml of water was withdrawn.No bleeding and no urethra damage was reported.
 
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Brand Name
BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
Type of Device
FOLEY CATHETER (SILICONE)
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7133081
MDR Text Key95728961
Report Number1018233-2017-06424
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/12/2021
Device Catalogue Number1758SI16
Device Lot NumberNGAP3870
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2017
Date Manufacturer Received02/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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