MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINE METER FOLEY TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER; METER TRAY

Model Number	902816
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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.The device was not returned.
Event or Problem Description
It was reported that the tray came with two syringes of 10cc lubricating jelly and did not have the 10cc sterile water.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿bard® 350ml urine meter foley tray preconnected to bardex® lubricath® foley catheter with bard ez-lok® sampling port caution: this product contains natural rubber latex which may cause allergic reactions.** contents: ** bardex lubricath foley catheter urine meter (350ml capacity) attached to drainage bag (2500ml approx.Vol.) bard ez-lok® sampling port attached sheeting clip string hanger attached hooks control-fittm outlet device ¿ bard tamper-evident sea uro-preptm tray with: catheter lubricating jelly syringe (10cc) latex-free, powder-free gloves (2) underpad (waterproof) forceps/drape/prep balls (5) povidone-iodine solution specimen container, cap and label 10cc syringe (prefilled with sterile water) to inflate catheter only sterile: contents of inner wrap are sterile unless package has been opened or damaged.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Directions for use on reverse side.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.Directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use.1.Open csr wrap to form sterile field.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Pour cleansing solution onto 3 prep balls.6.Remove tip on catheter lubricating jelly syringe.7.Remove top tray.8.Open plastic pouch surrounding catheter.9.Lubricate catheter.10.Prepare patient with 3 saturated prep balls.Dry patient with remaining 2 prep balls.11.Proceed with catheterization in usual manner.To inflate catheter, insert tip of water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water.12.Hang the bag near the foot of the bed by using string and/or hook.13.Use sheeting clip to secure drainage tube to draw sheet.14.The urine meter may be emptied in two ways: a.To empty into the bag, grasp the bottom of the meter and lift up.To provide better meter drainage, lifting again is recommended.B.To empty urine meter into receptacle, twist green portion of the drain valve to the right.15.To empty bag: a.Remove outlet tube from housing; gently squeeze connector arms and pull tube from housing.B.Release clamp and empty bag.C.After emptying, reclamp outlet tube and slide connector into housing until connector arms engage.16.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.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.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Engage disengage control fit connector inflate with 10ml sterile water wait at least 30 seconds for balloon deflation 17.Periodic observations 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, the bag may have to be changed.18.If bag is not positioned correctly, urine may bypass the meter and go directly to the bag.Reposition bag as necessary.Tamper-evident seal disconnect instructions: if necessary to disconnect catheter and drainage tube connector, flex catheter as illustrated, grasp tab, and slowly pull along perforations until section is removed.Directions for using bard ez-lok® sampling port: bard ez-lok® sampling port accepts a luer-lock or slip tip syringe.1.Kink drainage tubing a minimum of 3 inches below the sampling port until urine is visible under the access site.2.Swab surface of site with antiseptic wipe.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 lock the syringe onto the sampling port.Note: improper penetration technique could cause formation of a drop of urine on the surface of the sampling port.Periodic observation of the sampling port is recommended.4.Aspirate desired volume of urine.5.Unkink tubing and send specimen to laboratory.Important: in any drainage collection system, the drainage tube should hang straight from bedside to the drainage collection unit.This helps permit good flow and helps minimize ascending infection due to urine pooling from bedside to collection device.Excess tubing should be arranged to permit "straight-line" drainage.".
Event or Problem Description
It was reported that the tray came with two syringes of 10cc lubricating jelly and did not have the 10cc sterile water.

• Brand Name: BARD® URINE METER FOLEY TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: METER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7408457
• Report Number: 1018233-2018-01115
• Device Sequence Number: 18841080
• Product Code: EZC
• UDI-Device Identifier: 00801741046117
• UDI-Public: (01)00801741046117
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 902816
• Device Catalogue Number: 902816
• Device Lot Number: NGCN1979
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1