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

Model Number 175814

Device Problem Difficult to Insert (1316)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/28/2022

Event Type  malfunction  

Event Description

It was reported that the patient had been self-catharized with a silicone foley catheter for the first time eight weeks ago.Customer stated that during insertion it was very painful and there was some bleeding.Patient reported that they used lubrication and also reported that the balloon on the catheter seemed to stick out farther on the silicone catheter than it did on the latex catheters.Stated that the patient had a stricture and was using 12 french intermittent catheters prior to switching to latex foley catheters and patient did not pretest the balloon.No medical intervention was reported.Per customer via phone on (b)(6) 2022, the customer was being treated for bacterial prostatitis and had been using the antibiotic, cephalexin, to treat urinary tract infection.The customer kept getting infections which is why they switched to current catheters.It is unknown if the device contributed to the urinary tract infection at this time.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient had been self-catharized with a silicone foley catheter for the first time eight weeks ago.Customer stated that during insertion it was very painful and there was some bleeding.Patient reported that they used lubrication and also reported that the balloon on the catheter seemed to stick out farther on the silicone catheter than it did on the latex catheters.Stated that the patient had a stricture and was using 12 french intermittent catheters prior to switching to latex foley catheters and patient did not pretest the balloon.No medical intervention was reported.Per customer via phone on 01jul2022, the customer was being treated for bacterial prostatitis and had been using the antibiotic, cephalexin, to treat urinary tract infection.The customer kept getting infections which is why they switched to current catheters.It is unknown if the device contributed to the urinary tract infection at this time.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "incorrect material formulation".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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" h11: section a through f - 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.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: 15015186
• MDR Text Key: 295899802
• Report Number: 1018233-2022-05445
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034152
• UDI-Public: (01)00801741034152
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 175814
• Device Catalogue Number: 175814
• Device Lot Number: NGGP0162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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