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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® ALL-SILICONE FOLEY CATHETER; LUBRISIL
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; LUBRISIL Back to Search Results
Model Number 73022L
Device Problems Material Invagination (1336); Difficult to Remove (1528); Material Deformation (2976)
Patient Problem Discomfort (2330)
Event Date 02/18/2019
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 3 way urinary catheter developed a ridge due to the ribbed section of the balloon folding back over itself.This made the catheter difficult to remove from the patient, allegedly causing them discomfort and potential risk post urological surgery.No medical intervention reported.
 
Manufacturer Narrative
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 the catheter.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.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.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.Do not use if package is damaged bard, bardex, and lubricath are trademarks and/or registered trademarks of c.R.Bard, inc.Single use do not resterilize manufacturer: 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.".
 
Event Description
It was reported that the 3 way urinary catheter developed a ridge due to the ribbed section of the balloon folding back over itself.This made the catheter difficult to remove from the patient, allegedly causing them discomfort and potential risk post urological surgery.No medical intervention reported.
 
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Brand Name
BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
Type of Device
LUBRISIL
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8523615
MDR Text Key142341074
Report Number1018233-2019-01995
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741034329
UDI-Public(01)00801741034329
Combination Product (y/n)N
PMA/PMN Number
K070558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number73022L
Device Catalogue Number73022L
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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