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

Catalog Number 123516A

Device Problem Device Handling Problem (3265)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/17/2022

Event Type  Injury  

Event Description

It was reported that the foley catheter could not be removed.Pumping maneuvers, cutting the funnel and shaft and a copper wire approach to the inflation lumen were performed, but the catheter could not be removed.Therefore, a balloon rupture was performed by puncture.The nurse who performed the catheter removal procedure applied strong suction pressure was the cause of the inability to remove the catheter and the problem was with the procedure.It was stated that the balloon was tried to be deflated by syringe and it was not deflated sufficiently.Usually, the balloon could be deflated within a few seconds.It was mentioned that health damage to the patient was unknown.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.A potential root cause for this failure mode could be the nurse who performed the catheter removal procedure applied strong suction pressure was the cause of the inability to remove the catheter and the problem was with the procedure.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: "warnings: method for use: do not inflate the balloon in the urethra.The urethra may be injured.Do not pull the catheter hard.The bladder/urethra may be injured.Applicable patients: patients with delirium who might pull out catheter when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.Contraindications: method for use: do not reuse.Do not resterilize.Be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).They may damage the device and may burst balloon.Do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.Catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.Applicable patients: do not use in patients who are or have been allergic to natural rubber latex.Shape, configuration and principles: bardia® silicone-coated foley catheter is a balloon catheter.There are different type variations, for example, 2way and 3way products.Material: balloon catheter: natural rubber latex; silicone coating.Sizes of catheters: available in sizes 12 to 30 every 2fr.Balloon catheter.Intended use & effect- efficacy: this device is designed to be placed in the bladder for the purpose of urinary drainage and bladder irrigation.Directions for use: method of use: the device is intended for single use only and is not reusable.Cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.Lubricate the distal end of the catheter with water-soluble lubricant.Insert catheter into the urethral meatus and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a needle-less syringe, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.Pull catheter to seat the balloon at the level of the bladder neck and secure placement.To deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water to drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered.Precautions for use: when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.When deflating balloon, do not aspirate with a syringe.The inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the catheter cannot be removed.When inserting catheter with a stylet, confirm that the stylet has reached the tip of the catheter, and make sure to keep the stylet in place inside the catheter during insertion.No substance except sterile water should be used to inflate the balloon.Do not wipe catheter surface with organic solvents such as alcohol.Do not aspirate urine through drainage funnel wall.Since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.When urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.When irrigating, open the cap of irrigation funnel and attach irrigation line or tube under aseptic technique.After use, close the cap.Precautions: precautions for use (exercise caution when using the device in the following patients).Exercise caution when using the device in patients with high urinary calcium levels as encrustation on the balloon surface, catheter occlusion or damage may occur.Important precautions: when catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.When any part of the balloon and/or the catheter is missing, consider removing them using a cystoscope.When it is difficult to remove catheter by deflating the balloon, take appropriate measures according to the section ¿troubleshooting¿.Troubleshooting: when it is difficult to remove catheter by deflating the balloon (expressed as ¿removal-difficult case¿ hereinafter), take appropriate measures according to the following procedures.The following two methods are available for removal-difficult cases.Non-rupture method (sterile water is withdrawn without bursting the balloon.) balloon-rupture method with balloon-rupture method, fragments of the ruptured balloon may remain in the bladder.Therefore, try non-rupture method first.Non-rupture method attach luer tip syringe to the inflation valve.Inject an additional amount of sterile water into the inflation lumen and pump the plunger.If situation wouldn't be improved with 1), sever the inflation funnel of valve.If situation wouldn¿t be improved with 2), sever the catheter shaft while holding it with forceps so that the distal segment may not be drawn into the urethra.If situation wouldn't be improved with 3), insert a needle into the inflation lumen and pump the plunger.If situation wouldn't be improved with 4), insert a fine steel wire through the inflation lumen of catheter.Balloon-rupture method: inject 100-200ml/cc of saline solution warmed to body temperature into the bladder through the drainage lumen, and then inject a large amount of water or 10-15 ml/cc of mineral oil into the balloon through the inflation lumen with a needle to induce rupture.After rupture of the balloon, irrigate the bladder.If situation wouldn't be improved with 1), attempt following procedures.Under the radioscopic observation, infuse a contrast medium into the bladder, and burst the balloon by suprapubic puncture of the bladder.In male patients, burst the balloon by puncture with a needle from the perineal (or suprapubic) region or through the rectum under ultrasonographic guidance.In female patients, burst the balloon by insertion of a needle along the urethra.Malfunction and adverse events: malfunction: catheter kinking, damage, rupture.Difficulty or failure to remove the device.Occlusion of catheter inner lumens.Encrustation.Accidental removal of the device due to leakage of sterile water or balloon rupture device damage due to inappropriate use adverse events: urinary-tract infection, hemorrhage, hematuria, allergy reaction to the device, calculus formation, edema, pain, discomfort, injury of bladder or urethral, urethritis, urinary incontinence, retained balloon fragments.Storage method and expiration date: storage: store in a dry, cool place away from heat, moisture, and direct sunlight.Expiration date: indicated on the direct package and the outer box.".

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• 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: 15699086
• MDR Text Key: 302693831
• Report Number: 1018233-2022-08215
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 123516A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• 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