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

Model Number 175816

Device Problems Inaccurate Flow Rate (1249); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the foley catheter would not drain urine after insertion.Complainant alleged that this resulted in patient harm.

Manufacturer Narrative

The reported event was unconfirmed.Visual evaluation of the returned samples noted five unopened (within sealed original packaging), un-used foley trays present.All five trays were opened and all components were present in all trays.The catheters were removed from the blue sheath and the sample port connector for evaluation.No visible defects were present on any of the catheter surfaces.Catheter balloons were all inflated with 10ml of a methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water).No inflation difficulties were noted with any of the catheters.Catheters were then tested for flow rate.All catheters met the 100cm^3/min minimum specification for 16 fr catheters.Catheters were then allowed to deflate.All five catheters deflated the full 10ml of methylene blue with no observable balloon cuffing or ridges present on the balloon after deflation.Dimensional evaluation was completed on all five returned catheters.All dimensions were found to be within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "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 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 the patient record * generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.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 using a separate, clean collection container for each patient 1.Wash hands and don clean gloves 2.Using proper aseptic technique open outer csr wrap 3.Place underpad 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 swabstick 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 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".

Event Description

It was reported that the foley catheter would not drain urine after insertion.Complainant alleged that this resulted in patient harm.It was later reported that the patient was undergoing a c-section when the catheter stopped draining urine.The nurse reported that the catheter initially drained urine but stopped during the procedure.The catheter was reportedly removed and replaced.The nurse reported that the drainage stopped again with the second catheter.A third catheter was placed which also stopped draining.The nurse reported that a bladder retractor was placed following these events.Clinical statement: a bladder retractor placed during a c-section is standard protocol.It is placed to pull the bladder away from the uterus so that the bladder is not nicked when cutting the uterus.Tschlager, rn.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: LUBRISIL FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7515040
• MDR Text Key: 108489827
• Report Number: 1018233-2018-01742
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• 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: 08/23/2018

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 Expiration Date: 06/30/2020
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGCN2018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 08/09/2018
• Supplement Dates FDA Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1