MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM

Catalog Number	A304914
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that customer received a foley tray with a syringe with some debris inside.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned photo sample noted one opened (without original packaging), sterile water syringe.Visual inspection of the photo sample noted unknown foreign material inside the sterile water syringe.This does not meet specification which states "product /assembly must be free from visible loose or embedded foreign matter equal or larger than an aggregate total of 0.6mm square or 1/16" in length per tappi dirt estimation chart".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 ¿no follow up to cleaning procedure in the production areas".However, there was insufficient information to confirm this potential root cause.The device history record review could not be performed without a lot number.The instructions for use were found adequate and state the following: ¿directions for use 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 coude catheter 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 peri-urethral 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.Open packet of povidone iodine and pour solution over 3 foam swabs 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.Note: if hospital policy permits, it is possible to inject lubricant directly into the urethra 12.With your non-dominant hand, elevate the penis, holding it perpendicular to the body without compressing the urethra.If the patient is not circumcised, retract the foreskin.Prepare patient with 3 foam swabs saturated in povidone iodine, using each swab for one swipe only.Note: cleanse the penis in a circular motion starting at the urethral meatus and working outward 13.Proceed with catheterization by inserting the catheter tip into the meatus with the curve facing upward.As the catheter is advanced within the urethra, the bump on the funnel should continue to face upward.Make sure the patient¿s penis is held perpendicular as the catheter is inserted and advanced.Note: some resistance may be felt as the catheter tip meets the external sphincter.Slightly twisting the catheter from side to side, while advancing it may help the catheter pass beyond this point.It may be necessary to withdraw the catheter a short distance, and attempt to re-advance it slowly.A.When catheter tip has entered bladder, urine will be visible in the drainage tube.B.Insert the catheter to the bifurcation to ensure the balloon is within the bladder.14.Inflate catheter balloon using entire 10ml of sterile water provided in the prefilled syringe.Note: use of less than 10 ml can result in an asymmetrically inflated balloon: 15.Once inflated, gently pull catheter until the inflated balloon is snug against the bladder neck.Note: if the patient is not circumcised, pull the foreskin back over the meatus to prevent swelling.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.Bard ez-lok sampling port (indicated by the blue stem in the port) accepts luer lock or slip tip syringes.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.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.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.¿ correction: g.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 or Problem Description
It was reported that customer received a foley tray with a syringe with some debris inside.Per additional information received on 28apr2024, no the observation was noted prior to insertion.The patient status was fine.No, never noted debris before hoping that was a first and last.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM
• Common Device Name: FOLEY TRAY
• 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: 19115982
• Report Number: 1018233-2024-02126
• Device Sequence Number: 17910295
• Product Code: EZC
• UDI-Device Identifier: 00801741104350
• UDI-Public: (01)00801741104350
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: A304914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown