Catalog Number 73022L |
Device Problems
Deflation Problem (1149); Difficult to Remove (1528)
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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.
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Event Description
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It was reported that the catheter balloon would not deflate after a nurse took a luer tip syringe and connected it to the inflation port and pulled back and got nothing.Allegedly, the catheter was removed by pulling hard on the catheter.No patient injury or medical intervention was required.
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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.
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Event Description
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It was reported that the catheter balloon would not deflate after a nurse took a luer tip syringe and connected it to the inflation port and pulled back and got nothing.Allegedly, the catheter was removed by pulling hard on the catheter.No patient injury or medical intervention was required.
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Manufacturer Narrative
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Received 1 foley catheter.The reported issue was found inconclusive due to the poor condition of the sample.Per visual inspection calcification was found inside of the catheter and the inflation valve.A functional evaluation could not be performed due to obvious condition of the returned sample.The balloon was removed from the catheter shaft in order to verify any discrepancies with the inflation notch and no problems were found, the inflation notch was well done.The inflation lumen was reviewed and no discrepancies were found along the shaft.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: "visually inspect the product for any imperfections or surface deterioration prior to use.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." (b)(4).
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Event Description
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It was reported that the catheter balloon would not deflate after a nurse took a luer tip syringe and connected it to the inflation port and pulled back and got nothing.Allegedly, the catheter was removed by pulling hard on the catheter.No patient injury or medical intervention was required.
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Search Alerts/Recalls
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