MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINE METER FOLEY CATHETER TRAY, BARDEX® ALL-SILICONE TEMP-SENSING FOLEY; TEMPERATURE SENSING CATHETER

Model Number 849408

Device Problems Inaccurate Flow Rate (1249); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2019

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 the catheter was leaking around the insertion site, but not into the catheter.The catheter was placed all the way to the hub and the bladder was pressed with no urine return.The catheter was removed and a new catheter was inserted without difficulty.Urine was immediately noted in the second catheter and the balloon was then inflated with no resistance.The complainant reported the first catheter was placed per policy and placement was correct with easy visualization and insertion.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be 'drainage lumen blocked¿ with a potential root cause of 'incorrect use of tool.¿ 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: ¿development released bard® ez-lok® sampling port (indicated by the blue stem in the port) accepts luer lock (fig.1a) or slip tip syringes (fig.1b).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.(fig.2) 3.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80 - 100 degree angle).Press the syringe firmly and twist gently to access the sampling port.(fig.3) 4.Slowly aspirate urine sample into syringe and remove syringe from sample port.(fig.4) 5.Unkink tubing 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.Www.Bardmedical.Com manufacturer: c.R.Bard, inc.8195 industrial blvd.Covington, ga 30014 usa 1.800.526.4455 sterilized using ethylene oxide 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.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.Urology cdc guidelines for appropriate indications for indwelling urethral catheter 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.* 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 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.To assist in healing of open sacral or perineal wounds.Patient requires prolonged immobilization.To improve comfort for end of life care.Patient has acute urinary retention or bladder outlet obstruction.Need for accurate urine output measurements.Use for selected surgical procedures urology.Pk7646071 05/2018".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 the catheter was leaking around the insertion site, but not into the catheter.The catheter was placed all the way to the hub and the bladder was pressed with no urine return.The catheter was removed and a new catheter was inserted without difficulty.Urine was immediately noted in the second catheter and the balloon was then inflated with no resistance.The complainant reported the first catheter was placed per policy and placement was correct with easy visualization and insertion.

• Brand Name: BARD® URINE METER FOLEY CATHETER TRAY, BARDEX® ALL-SILICONE TEMP-SENSING FOLEY
• Type of Device: TEMPERATURE SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9538908
• MDR Text Key: 178124118
• Report Number: 1018233-2020-00003
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029332
• UDI-Public: (01)00801741029332(10)
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 849408
• Device Catalogue Number: 849408
• Device Lot Number: NGCX4163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1