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

Model Number 175816

Device Problem Difficult to Insert (1316)

Patient Problems Skin Tears (2516); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/24/2022

Event Type  Injury  

Event Description

It was reported that the patient was being prepped a-fib ablation, intubated and sedated.During foley catheter placement the patient developed trauma in the urethral tract.Registered nurse inserted 16 fr foley catheter which advanced into urethra without resistance, but registered nurse did not note a urine return.Catheter was removed slightly, and rn noticed blood in catheter as well as blood surrounding the catheter.Rn stopped removal and called doctor from urology to assist.Medical doctor removed initial catheter and inserted coude tip catheter.Patient transported to post-anesthesia care unit (pacu) and patient was educated on events.Urology noted that the patient had urethral tear with the catheter having curled in the tip coming out of the meatus and was carefully removed.Stated that urojet was then used to instill and fill the urethra with lidocaine jelly.Also stated that a 16fr coude tip catheter was then used and with several manipulations was eventually able to be advanced into the bladder and clear yellow urine drained at that time.Balloon was inflated and the catheter was put to drainage bag.At that point there was no active bleeding from the urethra.

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.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "tortuous anatomy".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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: "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." 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 patient was being prepped a-fib ablation, intubated and sedated.During foley catheter placement the patient developed trauma in the urethral tract.Registered nurse inserted 16 fr foley catheter which advanced into urethra without resistance, but registered nurse did not note a urine return.Catheter was removed slightly, and rn noticed blood in catheter as well as blood surrounding the catheter.Rn stopped removal and called doctor from urology to assist.Medical doctor removed initial catheter and inserted coude tip catheter.Patient transported to post-anesthesia care unit (pacu) and patient was educated on events.Urology noted that the patient had urethral tear with the catheter having curled in the tip coming out of the meatus and was carefully removed.Stated that urojet was then used to instill and fill the urethra with lidocaine jelly.Also stated that a 16fr coude tip catheter was then used and with several manipulations was eventually able to be advanced into the bladder and clear yellow urine drained at that time.Balloon was inflated and the catheter was put to drainage bag.At that point there was no active bleeding from the urethra.

• 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: 14804996
• MDR Text Key: 294847295
• Report Number: 1018233-2022-04878
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 10/12/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 74 KG