C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL I. C. 2 WAY ALL-SILICONE FOLEY CATHETER WITH 5CC BALLOON.; FOLEY CATHETER (SILICONE)
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Catalog Number 1758SI14 |
Device Problems
Fluid/Blood Leak (1250); Mushroomed (2987)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/30/2016 |
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.
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Event Description
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It was reported that during the pretest, the catheter leaked water.The balloon was allegedly damaged, and a mushroom/ridge was identified.It was later reported, that an in-house observation, noted no damage to the balloon of the returned sample.There were no missing pieces.
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Manufacturer Narrative
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Received 1 silicone catheter.The reported event was confirmed as cause unknown based on the preliminary visual evaluation.Per the visual evaluation of the returned sample, a cuff roll was not observed.During the functional evaluation, a cuff roll was not formed.The dimensional evaluation of the catheter was found within specification.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: "caution: do not aspirate urine through drainage funnel wall.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Recommended inflation capacities: 3cc balloon: use 5cc sterile water.5cc balloon: use 10cc sterile water.30cc balloon:use 35cc sterile water.Do not exceed recommended capacities.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
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Event Description
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It was reported that during the pretest, the catheter leaked water.The balloon was allegedly damaged, and a mushroom/ridge was identified.It was later reported, that an in-house observation, noted no damage to the balloon of the returned sample.There were no missing pieces.
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Search Alerts/Recalls
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