Model Number 0070740 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2020 |
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.
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Event Description
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It was reported that foreign material like a melted plastic was found inside the device before use.
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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 foreign material like a melted plastic was found inside the evacuator before the use.
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Manufacturer Narrative
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The reported event was unconfirmed because the reported failure could not be reproduced.The reported failure is considered within specification as the reported failure could not be reproduced.The product was not used for treatment.The product had not caused the reported failure.A dhr review was not required as the investigation was unconfirmed.A labeling review was not performed because labelling could not have prevented the reported failure.H11: section a through f - 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.H3 other text : the actual/suspected device was evaluated.
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Event Description
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It was reported that foreign material like a melted plastic was found inside the evacuator before use.
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Search Alerts/Recalls
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