Model Number 166820 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
No Patient Involvement (2645)
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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 tip of the catheter broke off.It was later reported that the lumen of the balloon detached from the catheter.The event happened outside of the patient.
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Manufacturer Narrative
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The reported event was confirmed as cause unknown.Received 1 used silicone foley catheter for evaluation.The visual inspection noted that the inflation port was cut and had a cuff roll.No other defects were observed.Per the dimensional evaluation, the catheter active length 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: "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 the tip of the catheter broke off.It was later reported that the lumen of the balloon detached from the catheter.The event happened outside of the patient.Per the sample evaluation, there was a mushroom shaped balloon.
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Search Alerts/Recalls
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