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

Catalog Number 165816

Device Problems Material Fragmentation (1261); Material Puncture/Hole (1504)

Patient Problem Pain (1994)

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported that the customer had an issue with two foley catheters on (b)(6).The first foley they inserted on a patient and found that the balloon would not inflate due to a crack in the port.(batch# nghq2187) the second catheter they inserted was successful, but found that it fell out of the patient after a few minutes, despite the balloon being inflated.When they investigated further and injected water into the balloon port (now out of the patient) they found two puncture holes in which water was squirting out of.(batch# nght0770) they saved both catheters and had the lot number.Both were the surestep foley tray system 16 fr.Also stated that foley cathters were defective.Patient experienced pain, inaccurate monitoring.

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.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.Received one (1) used 2 way catheter (without original packaging).Visual inspection noted 0.025" pinhole found on funnel.This is out of specification per inspection procedure, 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.A potential root cause for this failure could be imperfection in balloon due to process.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: ¿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 directions for use wash hands and don clean gloves 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 inora 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 ntered 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¿.Correction: d, f, h 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the customer had an issue with two foley catheters on lakeside 55.The first foley they inserted on a patient and found that the balloon would not inflate due to a crack in the port.(batch# nghq2187) the second catheter they inserted was successful, but they found that it fell out of the patient after a few minutes, despite the balloon being inflated.When they investigated further and injected water into the balloon port (now out of the patient) they found two puncture holes in which water was squirting out of.(batch# nght0770) they saved both catheters and had the lot number.Both were the sure-step foley tray system 16 fr.It also stated that foley catheters were defective.The patient experienced pain and inaccurate monitoring.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "inspection results (visual characteristics).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 states the following: ¿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.Directions for use: wash hands and don clean gloves.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 inora.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 ntered 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¿.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.H3 other text : the device was not returned.

Event Description

It was reported that the customer had an issue with two foley catheters on lakeside 55.The first foley they inserted on a patient and found that the balloon would not inflate due to a crack in the port.(batch# nghq2187) the second catheter they inserted was successful, but found that it fell out of the patient after a few minutes, despite the balloon being inflated.When they investigated further and injected water into the balloon port (now out of the patient) they found two puncture holes in which water was squirting out of.(batch# nght0770) they saved both catheters and had the lot number.Both were the sure-step foley tray system 16 fr.Also stated that foley catheters were defective.Patient experienced pain, inaccurate monitoring.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE 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: 17763958
• MDR Text Key: 323593555
• Report Number: 1018233-2023-06845
• Device Sequence Number: 1
• Product Code: EZL
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2023

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: 165816
• Device Lot Number: NGHQ2187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 10/10/2023; 12/05/2023
• Supplement Dates FDA Received: 10/17/2023; 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• 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