C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER; FOLEY CATHETER (LATEX)
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Catalog Number 0165L16 |
Device Problems
Deflation Problem (1149); Device Dislodged or Dislocated (2923)
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Patient Problems
No Consequences Or Impact To Patient (2199); 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 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.The device was not returned.
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Event Description
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It was reported that the catheter spontaneously fell out of the patient.Allegedly, the incident was apparently one of three in the past couple of weeks.
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Manufacturer Narrative
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The reported event was unconfirmed since the problem could not be reproduced.The evaluation observed no leakage even when pressure was applied on sac.The sample went under a 7 day leak test and no leakage was observed.There was no leakage from the valve.The catheter was dissected and no conditions were found that could have contributed to the reported event.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: ¿warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Valve type: use luer slip tip syringe.Do not use needle.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 of 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 patient.Visually inspect the product for any imperfections or surface deterioration prior to use.".
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Event Description
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It was reported that the catheter spontaneously fell out of the patient.Allegedly, the incident was apparently one of three in the past couple of weeks.
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Search Alerts/Recalls
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