MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER; 14F 5CC SLIPPERY S FOLEY

Model Number 175814

Device Problem Burst Container or Vessel (1074)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the catheter balloon broken after being placed for 2 hours.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met relevant specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to the silicone was too weak to withstand the normal forces applied during the use.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "directions for use: 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.1.Open outer white wrapping to prepare sterile field and place under pad beneath patient, plastic side down.2.If patient has a catheter insitu to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe stick in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, reseat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.Wait at least 30 seconds for deflation.If permitted by local protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by local protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.3.Put on gloves, cover patient with fenestrated drape with open exposing location positioned where catheter will be inserted, and place the apron on yourself.4.Using the two (2) syringes, marked ¿for cleansing purposes only dispense the water onto three (3) gauze squares.Prepare the patient by wiping down the catheter insertion site with the saturated gauze squares.Dry patient with the remaining two (2) gauze squares.Note: do not use this syringe to inflate the catheter balloon.5.Prepare the lubricating gel syringe by removing the cap from the syringe tip.6.For easing the insertion of the catheter into the patient dispense the lubricating gel into the urethra.(according to local protocol).7 remove top tray and open plastic pouch (sleeve) surrounding the catheter.8.Proceed with catheterization according to local protocol.To inflate catheter, simply insert tip of sterile water-filled syringe gently into valve do not over penetrate) and depress plunger.Instill entire amount of sterile water 10 ml.9.Attach statlock foley stabilization device to the bifurcation (y shape) of the foley catheter (statlock foley stabilization device can be used for up to 7 days) and apply.10.If the procedure pack includes a leg bag, utilize the leg straps provided to secure the leg bag to the patient¿s leg, making sure not to affect circulation or drainage of urine.11.Ensure catheter and drainage bag tubing is kink free and drainage bag is positioned below the bladder to ensure urine is flowing freely.Periodic inspection of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, further investigation should be taken in line with local protocol.1.Kink the drainage tubing at a minimum of 5 cm below the sampling port.2.Wipe the surface of the port with an alcohol swab.3.Using an aseptic technique, position the syringe (luer slip tip only) in the center, perpendicular to the surface of the port, and then press the tip of the syringe into the sampling port.4.Aspirate the desired volume and then remove the syringe.5.Wipe the surface of the port with an alcohol swab.6.Unkink the tubing and send the correctly labelled specimen to the laboratory." h11: section a through f - the information provided by bd 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 bd.H3 other text: the device was not returned.

Event Description

It was reported that the catheter balloon was broken after being placed for 2 hours.Per follow up with the customer via email on 15apr2021 the customer stated that no missing pieces of the balloon were observed.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER
• Type of Device: 14F 5CC SLIPPERY S FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10886639
• MDR Text Key: 217945361
• Report Number: 1018233-2020-21147
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034152
• UDI-Public: (01)00801741034152
• Combination Product (y/n): N
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

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: 175814
• Device Catalogue Number: 175814
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other