Model Number 0935280 |
Device Problem
Moisture Damage (1405)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/21/2021 |
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 there was moisture in the bulb syringe.
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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 patient treatment.The reported failure is considered within specification as the reported failure could not be reproduced.No root cause could be found because the reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (without original packaging), 1 used irrigation syringe bulb.Visual inspection of the sample noted no moisture or damage found on the return sample.The device was returned for evaluation.A device history record review was not required as the investigation was unconfirmed.The investigation is concluded, and no additional action is required at this time.As the reported event is unconfirmed a risk review and labeling review is not required.The actual/suspected device was inspected.
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Event Description
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It was reported that there was moisture in the bulb syringe.
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Search Alerts/Recalls
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