Catalog Number 0935280 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
No Patient Involvement (2645); 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.
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Event Description
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It was reported that there was a black piece of debris between bulb and syringe.
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Manufacturer Narrative
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The reported event was unconfirmed.Visual evaluation of the sample noted one opened (without original packaging) irrigation bulb syringe was received.It was noted that there was a small black speck measuring 0.25mm^2 between the barrel and the bulb.This was found to be within specification stating."loose foreign matter is not permitted in excess of a total aggregate of 0.6mm2 per tappi dirt estimation chart." the device history record was reviewed and found nothing that could have caused or contributed to the reported event."sec.801.116 medical devices having commonly known directions: a device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual." correction: concomitant medical products.
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Event Description
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It was reported that there was a black piece of debris between bulb and syringe.
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Search Alerts/Recalls
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