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

Model Number 0165SI24

Device Problem Dent in Material (2526)

Patient Problem Pain (1994)

Event Date 12/08/2020

Event Type  malfunction  

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 pain and foley catheter with a 5cc balloon leaked from the site (suprapubic catheter).So the patient decided to fill up the foley balloon outside the body and stated that the balloon was asymmetrical.No medical intervention reported.Per mss response, the foley balloon was only filled with 5cc of sterile water instead of 10cc.So the patient was informed of the correct amount and how not filling to the amount might lead to an asymmetrical balloon.Per follow up on 09dec2020, the customer noted that the catheters were being inflated with the full 10cc and not 5cc as initially stated.Also, the catheter was not drained while in place which caused leakage, so the customer removed the catheter and inflated.Upon inflation, the patient noticed that the balloon was inflating asymmetrically.

Event Description

It was reported that the patient had pain and foley catheter with a 5cc balloon leaked from the site (suprapubic catheter).So the patient decided to fill up the foley balloon outside the body and stated that the balloon was asymmetrical.No medical intervention reported.Per mss response, the foley balloon was only filled with 5cc of sterile water instead of 10cc.So the patient was informed of the correct amount and how not filling to the amount might lead to an asymmetrical balloon.Per follow up on 09dec2020, the customer noted that the catheters were being inflated with the full 10cc and not 5cc as initially stated.Also, the catheter was not drained while in place which caused leakage, so the customer removed the catheter and inflated.Upon inflation, the patient noticed that the balloon was inflating asymmetrically.

Manufacturer Narrative

The reported event was unconfirmed since the problem could not be reproduced.No root cause could be found because the reported event was unconfirmed.A potential root cause for this failure mode could be (example: operator error/user related/mechanical failure/ product mishandling/not follow as per ifu stated.The device history record review was not required as the reported event was unconfirmed.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a luer slip 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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.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 recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Catheters should be replaced in accordance with the cdc guideline, "guideline for prevention of catheter-associated urinary tract infection." at the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheter related adverse effect, the catheter should be replaced.Do not exceed recommended capacities.Sterile: unless package is opened or damaged.Do not use if package is opened or damaged.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Visually inspect the product for any imperfections or surface deterioration prior to use.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst." corrections: d, h.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.

• Brand Name: BARDEX I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11097785
• MDR Text Key: 224691918
• Report Number: 1018233-2020-22168
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016790
• UDI-Public: (01)00801741016790
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2024
• Device Model Number: 0165SI24
• Device Catalogue Number: 0165SI24
• Device Lot Number: MYDR6115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other