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

Catalog Number 175816

Device Problem Sharp Edges (4013)

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

Event Date 10/13/2022

Event Type  malfunction  

Event Description

It was reported that urologist doctor indicated that when inserting the urinary foley catheter into the patient's urethra, it generated a small bleeding which was visible at the tip of the catheter, for this reason, they removed the product from the patient, to use a kit of new installation of the same material and batch.At the time of entering a new installation kit, there was no longer any bleeding.The urologist doctor indicated that the catheter had a bit of burr in its tip and that this might have caused the bleeding.No medical intervention was reported.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event is inconclusive as samples received could not be evaluated for the reported event.Visual evaluation noted one photo sample received showcasing outer packaging of foley catheter kit.Outer packaging indicates lot number (nggs4627) and expiration date.Based on photo sample received the sample cannot be evaluated for the reported event.Therefore, it is unknown if the foley catheter meets specifications according.Although an exact root cause could not be determined potential root causes include tortuous anatomy and improper tolerancing (fit between the check valve/cap assembly and inflation funnel).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: "bard® ez-lok® sampling port (indicated by the blue stem in the port) accepts luer lock (fig.1a) or slip tip syringes (fig.1b).1.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.2.Swab surface of bard® ez-lok® sampling port with antiseptic wipe.(fig.2) 3.Using aseptic technique, position the syringe in the center of the sampling port.Press the syringe firmly and twist gently to access the sampling port.(fig.3) 4.Slowly aspirate urine sample into syringe and remove syringe from sample port.5.Unkink tubing if necessary and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.6.Follow established hospital protocol for specimen labeling and transport to lab.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.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 3.Use the provided packet of wipes to cleanse patient¿s periurethral area 2.Explain procedure to patient and open peri-care kit 4.Remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel 7.Place underpad beneath patient, plastic/¿shiny¿ side down note: use caution to maintain aseptic technique 6.Don sterile gloves 8.Position fenestrated drape on patient 11.Remove foley catheter from wrap and lubricate catheter 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 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 instructions for use) 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 14.Inflate the balloon with sterile water to the volume stated on the inflation lumen of the catheter by using a water-filled syringe.Do not exceed recommended capacities as stated on the inflation lumen of the catheter.12.Prepare patient with 3 foam swab sticks saturated in povidone iodine.Use the nondominant handfor 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 5.Using proper aseptic technique 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." the information provided by bd represents all 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.

Event Description

It was reported that urologist doctor indicated that when inserting the urinary foley catheter into the patient's urethra, it generated a small bleeding which was visible at the tip of the catheter, for this reason, they removed the product from the patient, to use a kit of new installation of the same material and batch.At the time of entering a new installation kit, there was no longer any bleeding.The urologist doctor indicated that the catheter had a bit of burr in its tip and that this might have caused the bleeding.No medical intervention was reported.Per follow up information received on 25oct2022, no intervention was required, only a new catheter was placed and the bleeding stopped.The doctor was wearing protective gear.The burr could not be seen with the naked eye, the doctor told them that it could be perceived by touch.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15674655
• MDR Text Key: 306991347
• Report Number: 1018233-2022-08125
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

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 Catalogue Number: 175816
• Device Lot Number: NGGS4627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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): Other