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The reported event was inconclusive due to lot samples being returned and it is unknown how the products reacted with the particular patient.It was unknown whether the device met relevant specifications.The product was used for treatment purposes.It is unknown whether the device caused the reported failure.Visual evaluation of the returned sample noted one unopened (inside original packaging), surestep foley tray system, including drain bag, tubing, and catheter.Visual inspection of the sample noted no visible defects.The catheter from the tray was visually evaluated and no physical abnormalities or rough surfaces were noted.Eyelets were present on the catheter.The drainage lumen on the catheter was flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water).No leakage or other issues were noted.Drainage was consistent with a normal catheter.Due to the fact that it is unknown how the products reacted with the particular patient, it is unknown whether or not the device caused a patient reaction.The drain bag was filled with methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).No leaks were noted from the bag.This is within specification per inspection procedure, which states, "no leakage permitted on the assembled bag." the catheter was confirmed to be size 16 fr.A potential root cause for the reported failure could be, ¿inadequate sterilization; failure of sterile barrier.¿ 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: ¿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.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.5.Unkink tubing if necessary 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.Pk7646068 05/2018 www.Bardmedical.Com manufacturer: bard medical division c.R.Bard, inc.8195 industrial blvd.Covington, ga 30014 usa 1.800.526.4455 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 resterilize.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 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 patient record 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 (e.G., prior to transport) using a separate, clean collection container for each patient ¿ routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate ¿ leave foley catheter in place only as long as needed" 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.
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