Catalog Number 0035630 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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It was reported that the catheter was not draining properly.The complainant alleged that the urine was coming down the side of the catheter and not through the tube.
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Manufacturer Narrative
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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: "davol infant cath kit instructions for use: 1.Open package and remove plastic wallet.2.Open plastic wallet.3.Place infant in supine position, thighs abducted.4.Cleanse the area around the meatus with povidone-iodine swabs.5.Put on sterile gloves.6.Place the tip of the catheter in sterile lubricant and catheterize patient.7.After urine is collected, pull catheter out of cap.8.Tighten cap and depress spout.9.Label centrifuge tube.Important: 1.Use plastic wallet as sterile field.2.Pull catheter out of centrifuge tube to the proper length immediately after donning gloves.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly.Contents: ¿ 5 fr.Catheter in centrifuge tube ¿ povidone-iodine swabs ¿ vinyl gloves ¿ 3 gm lubricant ¿ towel ¿ label reorder/ref: 0035630/5 fr.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Pk7644068 06/2016 sterilized by ethylene oxide.Single use.Do not resterilize.Do not use if package is damaged.Not made with natural rubber latex.Manufacturer: (b)(4).1-800-526-4455 www.Bardmedical.Com bard and davol are trademarks and/or registered trademarks of c.R.Bard, inc.Manufactured in mexico" (b)(4).
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Event Description
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It was reported that the catheter was not draining properly.The complainant alleged that the urine was coming down the side of the catheter and not through the tube.
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Search Alerts/Recalls
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