MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

Model Number 175816

Device Problem Deflation Problem (1149)

Patient Problems Urinary Retention (2119); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/16/2022

Event Type  Injury  

Event Description

It was reported that there was couple of incidents were the foley catheters were catching in the urethra which caused resistance, irritation and possible trauma on insertion and removal.Stated that the foley catheters became stuck on removal and on consultation with urology, stated that this has been a repetitive event with new foleys becoming stuck due to a new design sure step foley tray systems.It appeared they were silicone and have 2 ridges at the top and bottom of the foley tip.Also stated that the tip ridges were difficult to remove and urologist had to place urojet of lido to get it removed.

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 there was couple of incidents were the foley catheters were catching in the urethra which caused resistance, irritation and possible trauma on insertion and removal.Stated that the foley catheters became stuck on removal and on consultation with urology, stated that this has been a repetitive event with new foleys becoming stuck due to a new design sure step foley tray systems.It appeared they were silicone and have 2 ridges at the top and bottom of the foley tip.Also stated that the tip ridges were difficult to remove and urologist had to place turbojet of lido to get it removed.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "incorrect balloon design (balloon wall thickness excessive)".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities.Note: aggressive traction, particularly in the presence of suturing, is not recommended for silicone foley catheters.Bard, bardex and lubri-sil are registered trademarks of c.R.Bard, inc.Or an affiliate.U.S.Patent number 5,179,174 and patent pending.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.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.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." correction: g.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.H3 other text : the device was not returned.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13759117
• MDR Text Key: 287128059
• Report Number: 1018233-2022-01285
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention