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

Model Number 165816

Device Problems Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2020

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 there was a hole in the foley catheter.

Manufacturer Narrative

The reported event was confirmed, however the cause was unknown.Visual inspection noted that 2 photo samples shows one two-way silicone foley catheter was received.Visual evaluation noted that the catheter had a hole over the drainage lumen about halfway up to the shaft of the catheter.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure mode could be due to inappropriate material handling (silicone catheters).The product used for the treatment purposes.The product had failed to meet the specifications, and was influenced by the reported failure.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: "caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not re-sterilize.For urological use only.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.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/patient education information: insert foley catheters only for appropriate indications and leave in place only as long as needed.This catheter is intended for use in the drainage and/or collection and/or measurement of urine.Cdc guidelines for appropriate indications for indwelling urethral catheter use.Patient has acute urinary retention or bladder outlet obstruction ¿ need for accurate urine output measurements ¿ use for selected surgical procedures.To assist in healing of open sacral or perineal wounds ¿ patient requires prolonged immobilization ¿ to improve comfort for end of life care.Directions for use: 1.Wash hands and don't clean gloves.2.Using proper aseptic technique open outer csr wrap.3.Place under pad beneath patient, plastic/¿shiny¿ side down.4.Use the provided cleansing wipe to cleanse patient¿s peri-urethral area.5.Remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel.6.Don sterile gloves.7.Position fenestrated drape on patient.8.Remove top tray and place next to bottom tray (keep on csr wrap).9.Attach the water filled syringe to the inflation port.Note: it is not necessary to pre-test the foley catheter balloon.10.Remove foley catheter from wrap and lubricate catheter.11.Prepare patient with packet of pre saturated antiseptic swab sticks.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 swab stick cleanse the middle area between the labia minora male patient: cleanse the penis in a circular motion starting at the urethral meatus and working outward.12.Proceed with catheterization in usual manner.When catheter tip has entered bladder, urine will be visible in the drainage tube.Insert catheter two more inches and inflate catheter balloon.13.Inflate catheter balloon using sterile water and fill with recommended volume as referenced on product label.Note: using less than the recommended volume of sterile water can result in asymmetrically inflated balloon.Properly inflated with recommended volume of sterile water.Improperly inflated with less than the recommended volume of sterile water.14.Once inflated, gently pull catheter until the inflated balloon is snug against the bladder neck.15.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.16.Position hanger on bed rail at the foot of the bed note: exercise care to keep bag off the floor.17.Use green sheeting clip to secure drainage tube to the sheet.Make sure tube is not kinked.18.Indicate time and date of catheter insertion on provided labels.Place designated labels on patient chart and drainage system.19.Document procedure according to hospital protocol.".

Event Description

It was reported that there was a hole in the foley catheter.

• Brand Name: BARDEX ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10258670
• MDR Text Key: 199067883
• Report Number: 1018233-2020-04468
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Date Manufacturer Received: 08/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1