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

Catalog Number	A947316
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
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 the customer were having multiple incidents of foley catheter (b)(6)balloons not deflating.They had (b)(4) incidents.One affected catheter was saved (b)(6).
Event or Problem Description
It was reported that the customer were having multiple incidents of foley catheter (16french) balloons not deflating.They had 6 incidents.One affected catheter from tray a947316 was saved.Per sample form received on (b)(6) 2024, it was reported that the foleys placed, balloon inflated at the time of discontinuing the balloon would not deflate and sometimes inflate allowing to use it.Patient had no impact but previous denoted due to same issue and had to cut the tube to deflate the balloon.
Additional Manufacturer Narrative
The reported event is confirmed due to the syringe.Visual evaluation noted received 1silicone foley catheter with drainage bag attached and returned syringe without original package.Using returned syringe inflated balloon with 10 ml methylene blue solution (3 drops 1 percentage aq methylene blue per 100ml distilled water).Balloon inflated properly but did not deflate passively under 5 minutes.Therefore, balloon was inflated with 10 ml methylene blue solution (3 drops 1 percentage aq methylene blue per 100ml distilled water) using in house leur lock syringe.Catheter inflated properly and deflated passively under one minute.Balloon was dissected and the inflation notch was adequate punched.Therefore, the reported event is confirmed due to the syringe and does not meet specifications which states "catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.".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 lumen collapses under the pressure of the balloon.However, there was insufficient information to confirm this potential root cause.A dhr review did not show any problems or conditions that would have contributed to it.The instructions for use were found adequate and state the following: ¿directions for use proper techniques for urinary catheter 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.1.Wash hands and don clean gloves.2.Explain procedure to patient and open peri-carekit.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.Use proper aseptic technique open csr wrap.6.Don sterile gloves.7.Place underpad beneath patient plastic/"shiny¿ side down.8.Position fenestrated drape on patient.9.Structures 3 foam swabsticks in povidone iodine.10.Remove foley catheter from wrap and lubricate catheter.11.Attach the water filled syringe 12.Prepare patient with 3 foam swabsticks saturated in povidone iodine.Use the nondominant hand for the genitalia and the dominant hand for the swabs.Note: use each swabstick for one swipe only female patient: with a downward stroke cleanse the far labia minora and discard the swab.Do the same for the near 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 the 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 smlock® foley stabilization device if provided (see smlock®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, careshould be taken to assure that all balloon fragments have been removed from the patient.Proper techniques for urinary catheter maintenance secure the foley catheter, use the smlock®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.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.Bard®ez·lok'" sampling port (indicated by the blue stem in the port) accepts luer lock or slip tip collection devices.Bo vacutainer" urine products can be used for collection, storage, and transport of urine specimens from a foley catheter.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-lo,·· sampling port with antiseptic (fig.2) e.G., site-scrub'" ipa device which is an effective disinfecting luer hubs.Using aseptic technique, position device in the center of the sampling device firmly and twist gently to sampling port.If using bo vacutainer®, access sheath collect urine into the bd per hospital protocol.If using syringe, slowly aspirate urine sample into syringe collection cup or follow hospital.After sample is obtained confirm unkinked and urine is flowing freely obstructed.Discard collection dev hospital protocol.Follow established hospital protocol for specimen labeling and caution: federal (u.S.A.) law restricts this device to sale by or on a physician.Single use only.Do not resterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Of in accordance with accepted medical practices and applicable federal laws and regulations.Visually inspect the product for any imperfections or surface deter 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.¿ correction: d,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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER
• 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: 18766424
• Report Number: 1018233-2024-00936
• Device Sequence Number: 18091507
• Product Code: EZL
• UDI-Device Identifier: 00801741074141
• UDI-Public: (01)00801741074141
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: A947316
• Device Lot Number: NGHV3993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2023
• 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