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

Model Number 119316M

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient had to replace now 5 foley catheter this past week due to the catheters clogging, hence it was unable to flush them.While removed the catheter, the end was completely clogged with sediment.For this reason customer skeptical that it was a product defect of any kind.Customer stated that it had happened 5 times within one week.Stated only 3 patients but it had happened twice on 2 different patients and look at the urine, none of them look overly sediment.Per followup on (b)(6) 2021, it was reported that the lot numbers of the temp foleys that were on the unit at the time of the issue was ngfn2849 and ngfq4012.Also stated that the patient had discomfort.In the case of one patient, they assumed decreased urine output was due to condition.In fact, once the bladder scanned, patient's bladder had over a liter of urine and had been proned for hours so they did not done it earlier.No medical intervention was reported.

Event Description

It was reported that the patient had to replace now 5 foley catheter this past week due to the catheters clogging, hence it was unable to flush them.While removed the catheter, the end was completely clogged with sediment.For this reason customer skeptical that it was a product defect of any kind.Customer stated that it had had happened 5 times within one week.Stated only 3 patients but it had happened twice on 2 different patients and look at the urine, none of them look overly sediment.Per follow up on 24may2021, it was reported that the lot numbers of the temp foleys that were on the unit at the time of the issue was ngfn2849 and ngfq4012.Also stated that the patient had discomfort.In the case of one patient, they assumed decreased urine output was due to condition.In fact, once the bladder scanned, patient's bladder had over a liter of urine and had been proned for hours so they did not done it earlier.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used temperature sensing foley catheter received with meter bag.Visual inspection of the sample noted noticeable amount of sediments in both the catheter and meter bag.The catheter was injected with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), and the flow was restricted in the catheter due to the sediments.This is out of specification per inspection procedure, which states, "visually check that there¿s no material in murphy eye or drainage lumen." a potential root cause could be tooling misalignment.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: "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.Do not resterilize.For urological use only.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.Bard, ez-lok and statlock are trademarks and/or registered trademarks of c.R.Bard, inc.©2018 c.R.Bard, inc.All rights reserved.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.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.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.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 note: it is not necessary to pre-test the foley catheter balloon directions for use 1.Wash hands and do clean gloves 3.Use the provided packet of wipes to cleanse patient¿s periurethral area 2.Explain procedure to patient and open peri-care kit 3.Remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel 4.Place underpad beneath patient, plastic/¿shiny¿ side down note: use caution to maintain aseptic technique 5.Don sterile gloves 6.Position fenestrated drape on patient 7.Remove foley catheter from wrap and lubricate catheter 8.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 8.Once inflated, gently pull catheter until the inflated balloon is snug against the bladder neck 9.Secure the foley catheter to the patient use the statlock® foley stabilization device if provided (see statlock® foley stabilization device ifu) 10.Position hanger on bed rail at the foot of the bed 11.Use green sheeting clip to secure drainage tube to the sheet.Make sure tube is not kinked.13.Indicate time anddate of catheter insertion on provided labels.Place designated labels on patient chart and drainage system 14.Document procedure according to hospital protocol 15.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 note: use each swab stick for one swipe only 14.Using proper aseptic technique open csr wrap 15.Saturate 3 foam swab sticks in povidone iodine 16.Attach the water filled syringe to the inflation port 17.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." correction: d,h.H11: section a through f - 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: TEMP SENSING 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11926504
• MDR Text Key: 253991492
• Report Number: 1018233-2021-03219
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039911
• UDI-Public: (01)00801741039911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

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 Model Number: 119316M
• Device Catalogue Number: 119316M
• Device Lot Number: NGEY3311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 11/20/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2020
• 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