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

Model Number A947316

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

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

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 was inserted into the patient 4 hours pre-surgery.The catheter was inflated with no difficulties.While attempting to remove foley, it would not deflate.The catheter was pushed into bladder to ensure bladder neck was not tensed up keeping balloon inflated.The syringe was pulled on slowly, pulled quickly, and about 1/2cc of air was pushed in without success.The inflation arm was then cut to allow fluid to drain which proved unsuccessful.Per follow up received from ibc representative on 27 july 2020, the balloon appeared to have a tear and did not require any surgical intervention for removal.Patient repositioned and foley ¿fell out¿.No medical intervention was required.

Event Description

It was reported that the foley was inserted into the patient 4 hours pre-surgery.The catheter was inflated with no difficulties.While attempting to remove foley, it would not deflate.The catheter was pushed into bladder to ensure bladder neck was not tensed up keeping balloon inflated.The syringe was pulled on slowly, pulled quickly, and about 1/2cc of air was pushed in without success.The inflation arm was then cut to allow fluid to drain which proved unsuccessful.Per follow up received from ibc representative on 27july2020, the balloon appeared to have a tear and did not require any surgical intervention for removal.Patient repositioned and foley ¿fell out¿.No medical intervention was required.

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 foley inserted into the patient 4 hours after the pre-surgery.The catheter inflated with no difficulties.While attempting to remove foley, it would not deflate.The catheter was pushed into the bladder to ensure the bladder neck was not tensed up keeping the balloon inflated.The syringe was pulled on slowly, pulled quickly, and about 1/2cc of air was pushed in without success.The inflation arm was then cut to allow the fluid to drain which proved unsuccessful.Per follow up received from the ibc representative on 27jul2020, the balloon appeared to have a tear and would not require any surgical intervention for removal.The patient repositioned and foley fell out.No medical intervention was required.

Manufacturer Narrative

The reported event was confirmed as a manufacturing related as only the manufacturing site has access to the inflation notch.The device used for the treatment.The device would not meet the specifications, and was influenced by the reported failure.Visual evaluation of the returned sample noted that one opened (no original packaging), used silicone foley.Visual inspection of the sample noted that there were no obvious visual defects observed.The catheter balloon inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) without leaks.The balloon rested with difficulty.The balloon was dissected to find that the inflation notch was not complete.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure mode could be due to "inadequate pressure on the machine to punch." 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: "directions for use: 1.Wash hands and don clean gloves.2.Explain procedure to patient and open peri-care kit.3.Use the provided packet of wipes to cleanse patient¿s periurethral area.4.Remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel.5.Using proper aseptic technique open csr wrap.6.Don sterile gloves.7.Place under pad beneath patient, plastic/¿shiny¿ side down note: use caution to maintain aseptic technique 8.Position fenestrated drape on patient.9.Saturate 3 foam swab sticks in povidone iodine.10.Attach the water filled syringe to the inflation port note: it is not necessary to pre-test the foley catheter balloon.11.Remove foley catheter from wrap and lubricate catheter.12.Prepare patient with 3 foam swab sticks saturated in povidone iodine.Use the nondominant hand for the genitalia and the dominant hand for the swabs.Note: use each swab stick for one swipe only female patient: with a downward stroke cleanse the right labia minora and discard the swab.Do the same for the left labia minora.With the last swab stick cleanse the middle area between the labia minora male patient: cleanse the penis in a circular motion starting at the urethral meatus and working outward.13.Proceed with catheterization in usual manner using the dominant hand a.When catheter tip has entered bladder, urine will be visible in the drainage tube b.Insert catheter two more inches and inflate catheter balloon.14.Inflate catheter balloon using entire 10cc of sterile water provided in the prefilled syringe note: use of less than 10cc can result in asymmetrically inflated balloon 15.Once inflated, gently pull catheter until the inflated balloon is snug against the bladder neck.16.Secure the foley catheter to the patient use the statlock® foley stabilization device if provided (see statlock® foley stabilization device ifu) note: please make sure patient is appropriate for use of statlock® stabilization device.17.Position hanger on bed rail at the foot of the bed note: exercise care to keep.Bag off the floor.18.Use green sheeting clip to secure drainage tube to the sheet.Make sure tube is not kinked.19.Indicate time and date of catheter insertion on provided labels.Place designated labels on patient chart and drainage system.20.Document procedure according to hospital protocol.Foley catheter removal 1.To deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve 2.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 3.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation 4.If the balloon will not deflate and 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 5.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.".

• 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 GA 30014
• MDR Report Key: 10378570
• MDR Text Key: 203113363
• Report Number: 1018233-2020-05018
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741074141
• UDI-Public: (01)00801741074141
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2020

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 Expiration Date: 11/30/2021
• Device Model Number: A947316
• Device Catalogue Number: 165824
• Device Lot Number: NGAY0785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/17/2020; 10/19/2020
• Supplement Dates FDA Received: 09/08/2020; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1