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

Model Number 165816

Device Problem Material Invagination (1336)

Patient Problems Pain (1994); Burning Sensation (2146); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that after the balloon was inflated, a ridge appeared approximately 1 inch below the tip.Complainant reported that when the balloon was deflated the ridge became so prominent, it folded back on itself.

Manufacturer Narrative

The reported event was unconfirmed.Visual evaluation of the returned sample noted one opened, used silicone catheter present.Visual inspection of the catheter surface noted no obvious defects.No ridges were noted on the balloon surface upon sample receipt.The catheter balloon was inflated with 10ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water).The balloon concentricity was observed to be 60:40, which was within specification (70:30 maximum).The catheter was allowed to rest for 60 min with no leaks observed.The catheter balloon was passively deflated, with the lower portion deflating slightly slower than the upper portion.However, no ridges or cuffing were observed on the balloon surface upon full deflation, which is within specification.The active length of the catheter balloon was measured (0.7110") and found to be within specification (0.6" - 0.9").The french size of the balloon after deflation was measured to be 20fr, which is within the +4fr size tolerance.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use was found adequate and states the following: "proper techniques for urinary catheter insertion, perform hand hygiene immediately before and after insertion, insert urinary catheters using aseptic technique and sterile equipment, use the smallest foley catheter possible, consistent with good drainage, document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in patient record.Proper techniques for urinary catheter maintenance: secure the foley catheter, use the statlock® foley stabilization device if provided, maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions, maintain unobstructed urine flow and keep the catheter and collection tube free from kinking, keep the collection bag below the level of the bladder or hips at all times empty the collection bag regularly (e.G., prior to transport) using a separate, clean collection container for each patient routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate leave foley catheter in place only as long as needed.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 underpad 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 swabstick 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¿.Sterilized using ethylene oxide: sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not resterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.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.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Www.Bardmedical.Com.Manufacturer: bard medical division (b)(4).Bard, ez-lok and statlock are trademarks and/or registered trademarks of c.R.Bard, inc.©2018 c.R.Bard, inc.All rights reserved." correction: date rec¿d by mfr.

Event Description

It was reported that after the balloon was inflated, a ridge appeared approximately 1 inch below the tip.Complainant reported that when the balloon was deflated the ridge became so prominent, it folded back on itself.Per additional information received on 30jul2018, the patient experienced pain and burning while removing the catheter.

• 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: 7732927
• MDR Text Key: 115605442
• Report Number: 1018233-2018-03108
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• 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: 11/19/2018

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: 02/28/2023
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGCP0855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1