Catalog Number 1251QCL |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Information (3190)
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Event Date 01/06/2016 |
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.The device was not returned.
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Event Description
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It was reported that the cartridge malfunctioned.The cartridge failed to deploy a seed.There was not further information available.
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Manufacturer Narrative
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The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: ¿in the event the quicklink¿ loader or cartridges become inoperable due to damage or malfunction, any or all components may be removed from the cartridges and implanted manually." additionally, there is a troubleshooting section which instructs on conditions where "pushing the dispense button does not eject any items or produces a partial dispense.".
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Event Description
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It was reported that the cartridge malfunctioned.The cartridge failed to deploy a seed.
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Search Alerts/Recalls
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