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

Catalog Number	119416M
Medical Device Problem Codes	Inability to Irrigate (1337); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that once inserted the foley catheter failed to drain the bladder.Bladder scan confirmed urine present and they removed the catheter and found the product to be defective.They were unable to flush water through the lumen of the catheter.Per additional information received via email on 08apr2024, it was reported that the customer had another foley catheter that did not work in cardiovascular operating room (cvor) and needed to be replaced intraoperatively that day.In each event, the temperature sensing foley catheter was inserted into the bladder successfully.Neither of these foley catheters produced urine return.Bladder scans post insertion confirmed urine present in the bladder.The foleys were removed in each event.They planned to look at the lot number of the affected product and pulled all foley kits with same lot number from inventory to be safe.They were very concerned that they might have other affected product throughout the hospital that was placing their patient at risk.This was now a patient safety issue and would like some kind of follow up from bd along with credit for all the kits that they were removing from inventory.
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.
Additional Manufacturer Narrative
The reported event was confirmed supplier related.Visual evaluation of the returned sample noted one opened (without original packaging), used foley catheter.Visual inspection of the sample noted the drainage lumen was flushed and obstruction was immediately evidenced due to the drainage lumen being clogged, the solution would not come out through the eyelets due to the drainage lumen being clogged.The catheter shaft was cut in two pieces, evidencing that the obstruction was not in the funnel.Further inspection allowed to locate the drainage lumen completely clogged (0.2025'') from the last balloon ring.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 ¿physiological obstruction¿.However, there was insufficient information to confirm this potential root cause.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: ¿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.
Event or Problem Description
It was reported that once inserted the foley catheter failed to drain the bladder.Bladder scan confirmed urine present and they removed the catheter and found the product to be defective.They were unable to flush water through the lumen of the catheter.Per additional information received via email on 08apr2024, it was reported that the customer had another foley catheter that did not work in cardiovascular operating room (cvor) and needed to be replaced intraoperatively that day.In each event, the temperature sensing foley catheter was inserted into the bladder successfully.Neither of these foley catheters produced urine return.Bladder scans post insertion confirmed urine present in the bladder.The foleys were removed in each event.They planned to look at the lot number of the affected product and pulled all foley kits with same lot number from inventory to be safe.They were very concerned that they might have other affected product throughout the hospital that was placing their patient at risk.This was now a patient safety issue and would like some kind of follow up from bd along with credit for all the kits that they were removing from inventory.Per customer follow up received on 17apr2024, it was reported that per initial complaint report, the exact allegation is that the foley catheter failed to drain the bladder.Per customer follow up received on 15may2024, customer returned another sample with material #119416m.

• Brand Name: BARDEX® LUBRICATH® TEMPERATURE SENSING FOLEY CATHETER
• Common Device Name: 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: 19111013
• Report Number: 1018233-2024-02082
• Device Sequence Number: 7706818
• Product Code: EZC
• UDI-Device Identifier: 00801741046148
• UDI-Public: (01)00801741046148
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/19/2024

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: 119416M
• Device Lot Number: NGHX1363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 07/20/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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