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

Model Number 897216

Device Problem Inadequate Instructions for Healthcare Professional (1319)

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

Event Date 02/07/2023

Event Type  malfunction  

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 foley catheter kits came with a 10ml saline syringe to inflate the balloon with instructions to inflate all 10mls.Their students followed these instructions, however, the balloons all ruptured inside of their mannequins.When they went to assist and noted that the foley balloons included with the kits were only 5ml capacity.Therefore, there were misleading or inaccurate instructions and incompatible supplies provided with this kit and they had to disassemble the mannequins and remove the saline now inside of them.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "vendor/printer error".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Open csr wrap to form sterile field and place underpad beneath patient, plastic side down.Put on cuffed gloves and position drape on patient.Open catheter lubricating jelly.Remove top tray and open plastic pouch surrounding catheter.Lubricate catheter.Prepare patient with povidone-iodine swab packet.Proceed with catheterization in usual manner.To inflate catheter, simply insert tip of water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water (10cc).Position hanger on bedside rail near foot of the bed and use sheeting clip to secure drainage tube to draw sheet.To empty bag: remove outlet tube from housing; gently squeeze connector arms and pull tube from housing.Release clamp and empty bag.After emptying, reclamp outlet tube and slide connector into housing until connector arms engage.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.11.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.Directions for using bard® ez-lok¿ sampling port: bard® ez-lok¿ sampling port accepts a luer-lock or slip tip syringe.Kink drainage tubing a minimum of 3 inches below the sampling port until urine is visible under the access site.Swab surface of site with antiseptic wipe.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80-100 degree angle).Press the syringe firmly and twist gently to lock the syringe onto the sampling port.Note: improper penetration technique could cause formation of a drop of urine on the surface of the sampling port.Periodic observation of the sampling port is recommended.Aspirate desired volume of urine.Unkink tubing and send specimen to laboratory." 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 the foley catheter kits came with a 10ml saline syringe to inflate the balloon with instructions to inflate all 10mls.Their students followed these instructions, however, the balloons all ruptured inside of their mannequins.When they went to assist and noted that the foley balloons included with the kits were only 5ml capacity.Therefore, there were misleading or inaccurate instructions and incompatible supplies provided with this kit and they had to disassemble the mannequins and remove the saline now inside of them.

• Brand Name: BARD® FOLEY TRAY WITH BARDEX® ALL SILICONE FOLEY CATHETER
• Type of Device: SILICONE 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16451792
• MDR Text Key: 310334852
• Report Number: 1018233-2023-01266
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741020322
• UDI-Public: (01)00801741020322
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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: 897216
• Device Catalogue Number: 897216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/03/2023
• 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