MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL FOLEY CATHETERS; UNKNOWN FOLEY CATHETER

Device Problems Inaccurate Flow Rate (1249); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

It was reported that through a clinical study of all-silicone hydrogel coated pediatric length foley catheter (d1758 (08-10e)), when asked if the product performed as intended and resulted in the clinical outcome of successful urinary drainage from the bladder or from the kidney with nephrostomy placement, the survey respondent stated that product did not perform as intended and gave the reasoning as sometimes there was leakage of urine witnessed besides, patient did face some pain also.In few cases the hydrogel coating was not effective.Also, when asked of complications while using the device, the survey respondent mentioned pain, bacteriuria catheter blockage and leakage.Medical intervention was unknown.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿bad fit with connector".The lot number was unknown; therefore, the device history record could not be reviewed.Although the product catalog number is unknown, the patient provided product catalogue number 1758 (12-24).The 1758 (12-24) share the same ifu.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 silicone.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, bardia, biocath and lubricath are trademarks and/or registered trademarks of c.R.Bard, inc.Single use only.Do not resterilize consult instructions for use.C.R.Bard, inc.Covington, ga 30014 usa 1 800 526 4455 www.Bardmedical.Com 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.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.¿ h11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that through a clinical study of all-silicone hydrogel coated pediatric length foley catheter (d1758 (08-10e)), when asked if the product performed as intended and resulted in the clinical outcome of successful urinary drainage from the bladder or from the kidney with nephrostomy placement, the survey respondent stated that product did not perform as intended and gave the reasoning as sometimes there was leakage of urine witnessed besides, patient did face some pain also.In few cases the hydrogel coating was not effective.Also, when asked of complications while using the device, the survey respondent mentioned pain, bacteriuria catheter blockage and leakage.Medical intervention was unknown.

• Brand Name: LUBRI-SIL FOLEY CATHETERS
• Type of Device: UNKNOWN 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: 14110817
• MDR Text Key: 289280715
• Report Number: 1018233-2022-02455
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• 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): Other