MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®

Model Number A300316A

Device Problems Misassembled (1398); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Patient Involvement (2645); 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 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.The device was not received.

Event Description

It was reported that the syringe did not have an opening.

Event Description

It was reported that the syringe did not have an opening.

Manufacturer Narrative

The device was not returned for evaluation.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: "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: 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.Pk7646068 05/2018.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, 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".

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Type of Device: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7913909
• MDR Text Key: 122034353
• Report Number: 1018233-2018-04449
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741073731
• UDI-Public: (01)00801741073731
• 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: 11/02/2018

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: 11/30/2020
• Device Model Number: A300316A
• Device Catalogue Number: A300416A
• Device Lot Number: NGCQ4031
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1