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

Model Number 165816

Device Problem Biocompatibility (2886)

Patient Problem Urinary Tract Infection (2120)

Event Date 09/17/2021

Event Type  Injury  

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 customer started using the old bard kits due to surestep production issues.It was stated that utmb health league city campus started using them about 5 weeks ago and clear lake campus started using them approximately 2 weeks ago.The customer noticed a great increase in catheter associated urinary tract infection in league city campus and they were beginning to do the same at clear lake campus.It was stated that they started rounding with staff and they reported that these catheters leaked and they were having to replace them more than usual.It was stated that during bundle rounds the previous day, one patient was leaking and that day they suspected two catheters were leaking and discoloration was found on the statlock.The customer questioned whether there were any specific instructions for these catheters that could prevent this.It was unknown what medical intervention was provided for urinary tract infection.

Event Description

It was reported that the customer started using the old bard kits due to surestep production issues.It was stated that utmb health league city campus started using them about 5 weeks ago and clear lake campus started using them approximately 2 weeks ago.The customer noticed a great increase in catheter associated urinary tract infection in league city campus, and they were beginning to do the same at clear lake campus.It was stated that they started rounding with staff, and they reported that these catheters leaked, and they were having to replace them more than usual.It was stated that during bundle rounds the previous day, one patient was leaking and that day they suspected two catheters were leaking and discoloration was found on the statlock.The customer questioned whether there were any specific instructions for these catheters that could prevent this.It was unknown what medical intervention was provided for urinary tract infection.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be "materials of construction are not biocompatible".The device was not returned for evaluation.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: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use.1.Open csr wrap to form sterile field.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Pour cleansing solution onto prep balls.6.Remove tip on catheter lubricating jelly syringe.7.Open plastic pouch surrounding catheter.8.Lubricate catheter.9.Prepare patient with saturated prep balls.10.Proceed with catheterization in usual manner.See caution on reverse side.To inflate catheter, insert tip of water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water.11.Hang the bag near the foot of the bed by using string and/or hook.12.Use sheeting clip to secure drainage tube to draw sheet.13.The urine meter may be emptied in two ways: a.To empty into the bag, grasp the bottom of the meter and lift up.To provide better meter drainage, lifting again is recommended.B.To empty urine meter into receptacle, twist green portion of drain valve to the left; to close, twist green portion of the drain valve to the right.14.To empty bag: a.Remove outlet tube from housing; gently squeeze connector arms and pull tube from housing.B.Release clamp and empty bag.C.After emptying, reclamp outlet tube and slide connector into housing until connector arms engage.15.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.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.16.Periodic observations of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed.17.If bag is not positioned correctly, urine may bypass the meter and go directly to the bag.Reposition bag as necessary." correction: e.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.

• Brand Name: BARDEX® 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12576822
• MDR Text Key: 274748118
• Report Number: 1018233-2021-06202
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• 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: 03/15/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGEY1072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• 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