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

Model Number 165818

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

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 by the health care professional that the balloon of the catheter made the foley difficult to remove.The catheter was being used suprapubically and the patient had to be sent to the operating room for removal.The surgeon was able to remove the foley by pulling it out of the patient without injury.The complainant stated that the issue appeared to be caused by incorrect technique being used to remove the foley.

Manufacturer Narrative

The reported event was inconclusive as the device was not returned for evaluation.A potential failure mode could be ¿incorrect syringe used.¿.A potential root cause for this failure could be "user oversight, user did not follow procedure".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: "[directions for use] 1) method of use the device is intended for single use only and is not reusable.2) precautions for use 1) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.2) lubricate catheter shaft with water-soluble lubricant.3) carefully insert catheter into the urethral meatus, and advance it until the balloon enters the bladder.Using a needleless syringe, and gently infuse the specified volume of sterile water into the valve to inflate the balloon.Never inflate the balloon without first establishing urine flow which assures that the catheter is in the bladder and there are no obstructions to urine flow.4) pull catheter slightly to seat the balloon at the level of the bladder neck and secure placement.5) to deflate balloon and remove catheter, gently insert a luer tip (needleless) syringe in the inflation valve.Even without aspiration, sterile water in the balloon will come out spontaneously through balloon deflation.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered.[precautions] 1.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.2.Important precautions ·read all instructions for use prior to use and follow them.·this product is a medical device for qualified physicians, and should not be used for any other purpose.·this product is a disposable, supplied sterile.If package is opened or expiration date has passed, do not use.Do not resterilize.·for instructions regarding other medical equipment and/or medication used in conjunction, refer to the appropriate manufacturer ifus.·when abnormal resistance is encountered in inserting catheter, do not use excessive force, and remove the catheter to find out the cause of difficulty in insertion.·when inflating balloon, use sterile water of the prescribed capacity labeled on the valve.If the valve is labeled as 5 ml/cc, use 5 ml, if 10 ml/cc, use 10 ml, if 30ml/cc, use 30ml of sterile water.·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.·to inflate or deflate the balloon, use a luer tip (needleless) syringe.In deflate the balloon, do not aspirate or manually accelerate the deflation of the balloon.If difficult to come out the water spontaneously, refer to ¿troubleshooting¿ as follows." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported by the health care professional that the balloon of the catheter made the foley difficult to remove.The catheter was being used suprapubically and the patient had to be sent to the operating room for removal.The surgeon was able to remove the foley by pulling it out of the patient without injury.The complainant stated that the issue appeared to be caused by incorrect technique being used to remove the foley.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9134048
• MDR Text Key: 162472761
• Report Number: 1018233-2019-06021
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029769
• UDI-Public: (01)00801741029769
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

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: 165818
• Device Catalogue Number: 165818
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention