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The device was not returned for evaluation.A potential failure mode could be ¿collapsed lumen under balloon¿ with a potential root cause of "wrinkled rubberize or poor inflation lumen coverage".The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿intended for use in the drainage and/or collection and/or measurement of urine in adult and pediatric patients of compatible anatomical size.Drainage is accomplished by inserting the catheter through the urethra and into the bladder.For urological use only.Contraindications: ¿ none known.Warnings: ¿ do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause the balloon to burst.¿ this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.¿ after use, this product may be a potential biohazard.Handle and dispose of in accordance with acceptable medical practice and applicable laws and regulations.Cautions/precautions: ¿ maximum indwelling time should be less than 30 days.¿ urethral strictures, false passages, prostatic enlargement, and post-surgical bladder neck contractures can make urethral catheterization difficult and may require the services of a urologist.¿ do not aspirate urine through drainage funnel.¿ do not use if package is damaged.¿ storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.¿ consult accompanying documents.¿ federal (usa) laws restrict this device to sale by or on the order of a physician.Adverse reactions: as with any foley catheter, there is a potential for adverse reactions that may occur as part of use of this device including, but not limited to: ¿ urinary tract infection ¿ infection ¿ balloon rupture ¿ difficulty deflating the balloon ¿ difficulty removing the catheter ¿ blockage directions: after considering alternatives, determine if patient meets appropriate indications for foley catheterization.Select smallest french size possible consistent with good drainage.Select appropriate drainage collection system based on patient need (i.E.Urine meter, standard bag).Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfections of surface deterioration is observed, do not use.Catheterization should be performed adhering to the principals of asepsis utilizing sterile equipment and supplies.Gather sterile equipment necessary for the completion of an aseptic foley catheter insertion.This may include the following: clean gloves, perineal cleansing supplies, patient education materials, sterile gloves, drapes, underpad, collection system, 10ml sterile water in syringe, water soluble lubricant, antiseptic solution and 3 applicators, foley securement device.1.Wash hands and don clean gloves.2.Explain procedure to patient.3.Provide perineal cleaning per hospital protocol.4.Remove gloves and wash hands.5.Use drape to create sterile field between patient¿s legs and prepare equipment.6.Don sterile gloves.7.Place underpad beneath patient.8.Position fenestrated drape on patient.9.Attach sterile water syringe to inflation lumen.10.Remove foley catheter from packaging.Note: it is not necessary to pre-test the foley catheter balloon.Attach foley catheter to drainage tubing.Lubricate catheter.Cleanse the patient with antiseptic solution per hospital protocol.Manufacturer: c.R.Bard, inc.Covington, ga 30014 usa 1-800-526-4455 www.Bardmedical.Com bard, comfortguard and vertus are trademarks and/or registered trademarks of c.R.Bard, inc.Units do not use if package is damaged.Caution do not resterilize.Single use keep away from sunlight.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with acceptable medical practice and applicable laws and regulations.Sterilized using ethylene oxide caution: federal (usa) law restricts this device to sale by or on the order of a physician.Copyright © 2018, c.R.Bard, inc.All rights reserved.Female patient: with a downward stroke cleanse the right labia minora and discard the applicator.Do the same for the left labia minora.With the last applicator 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.11.Insert catheter maintaining aseptic technique.Female: when catheter tip has entered bladder, urine will be visible in the drainage tube.Insert catheter two more inches.Male: when the catheter tip has entered the bladder, urine will be present in the tube.Advance the catheter to the bifurcation or as far as hospital policy permits.12.Inflate catheter balloon using 10cc of sterile water.Note: use of less than 10cc can result in an asymmetrically inflated balloon.13.Once inflated, gently pull catheter until the inflated balloon is snug against the bladder neck.14.Secure the foley catheter per hospital protocol.15.Position hanger on bed rail at the foot of the bed.Note: exercise care to keep bag off the floor.16.Document procedure according to hospital protocol.Recommended inflation capacities: 5cc balloon: use 10ml sterile water foley catheter removal: 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.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 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.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Made in usa.Packaged in mexico" 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.
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