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

Model Number 175814

Device Problem Decrease in Pressure (1490)

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

Event Date 12/03/2020

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 when patient moved to operating room table emergent cesarean the nurse found the foley catheter laying on bed.Later a new catheter was inserted and proceeded with the surgery.The nurse re-inflated the bulb and noted that the fluid slowly leaked out of the balloon.Unfortunately, the catheter was thrown out at the end of the case.Per follow up via email on 09dec2020, the customer stated that the 10cc¿s of fluid was used to inflate the balloon on the catheter.The catheter was placed about 2 hours before the issue was noticed and they transferred patient to or table causing tension on the tube and it came out.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to imperfection in balloon due to process.It was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.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 in-situ - 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, re-seat 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.(refer to the instructions for use provided with the statlock foley stabilization device pouch for more details).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." correction: h 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.

Event Description

It was reported that when the patient moved to operation room table of emergency cesarean the nurse found the foley catheter lied on the bed.Later a new catheter was inserted and proceeded with the surgery.The nurse reinflated the balloon and noted that the fluid slowly leaked out of the balloon.Unfortunately the catheter was thrown out at the end of the case.Per follow up via email on (b)(6) 2020 the customer stated that the 10 ml fluid was used to inflate the catheter balloon.The catheter was placed about 2 hours before the issue was noticed and they transferred the patient to the operating room table caused the tension on the tube and it came out.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11078172
• MDR Text Key: 223803514
• Report Number: 1018233-2020-22054
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• 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
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other