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

Catalog Number 1758SI16

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  malfunction  

Event Description

It was reported that tip of the foley catheter was not present, only the drainage tube.While no patient harm was reported.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - 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 tip of the foley catheter was not present, only the drainage tube.While no patient harm was reported.

Manufacturer Narrative

The reported event was confirmed as cause unknown.The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be incorrect set- up.Incorrect tooling.However, there was insufficient information to confirm this potential root cause.Two photos were received for evaluation.In the first photo is evidenced the top part of the shaft without the balloon or tip.The shaft appears cut.The second photo shows the foley catheter tray label.Reported event is confirmed, photo sample received does not meet specifications which states "catheter length must conform to drawing." and "ball position according to work instructions.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: ¿directions for use/patient education information insert foley catheters only for appropriate indications and leave in place only as long as needed.This catheter is intended for use in the drainage and/or collection and/or measurement of urine.* cdc guidelines for appropriate indications for indwelling urethral catheter use patient has acute urinary retention or bladder outlet obstruction need for accurate urine output measurements use for selected surgical procedures to assist in healing of open sacral or perineal wounds patient requires prolonged immobilization to improve comfort for end of life care 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 the patient record.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.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 using a separate, clean collection container for each patient directions for use wash hands and don clean gloves using proper aseptic technique open outer csr wrap place underpad beneath patient, plastic/¿shiny¿ side down use the provided cleansing wipe to cleanse patient¿s peri-urethral area remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel don sterile gloves position fenestrated drape on patient remove top tray and place next to bottom tray (keep on csr wrap) attach the water filled syringe to the inflation port.Note: it is not necessary to pre-test the foley catheter balloon remove foley catheter from wrap and lubricate catheter prepare patient with packet of pre-saturated antiseptic swab sticks 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 proceed with catheterization in usual manner.When catheter tip has entered bladder, urine will be visible in the drainage tube.Insert catheter two more inches and inflate catheter balloon.Inflate catheter balloon using sterile water and fill with recommended volume as referenced on product label.Note: using less than the recommended volume of sterile water can result in asymmetrically inflated balloon properly inflated with recommended volume of sterile water improperly inflated with less than the recommended volume of sterile water once inflated, gently pull catheter until the inflated balloon is snug against the bladder neck 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.Position hanger on bed rail at the foot of the bed note: exercise care to keep bag off the floor use green sheeting clip to secure drainage tube to the sheet.Make sure tube is not kinked indicate time and date of catheter insertion on provided labels.Place designated labels on patient chart and drainage system 19.Document procedure according to hospital protocol foley catheter removal 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 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 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 should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Bard® ez-lok® sampling port (indicated by the blue stem in the port) accepts luer lock (fig.1a) or slip tip syringes (fig.1b).Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.Swab surface of bard® ez-lok® sampling port with antiseptic wipe.(fig.2) using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80 - 100 degree angle).Press the syringe firmly and twist gently to access the sampling port.(fig.3) slowly aspirate urine sample into syringe and remove syringe from sample port.(fig.4) unkink tubing and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.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 re-sterilize.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.¿ section a through f - 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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. 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: 18581113
• MDR Text Key: 334175518
• Report Number: 1018233-2024-00261
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741025228
• UDI-Public: (01)00801741025228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: 1758SI16
• Device Lot Number: NGHU1078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• 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