Catalog Number 0250070520 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/27/2015 |
Event Type
malfunction
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Event Description
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It was reported that black spots were noticed inside the package.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Manufacturer Narrative
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The cosmetic appearance failure mode of black spots could not be confirmed since no unit was returned.Most probable root causes are: 1.Manufacturing/assembly error; 2.Incorrect or inadequate packaging; 3.Severe shipping conditions.Since the unit was not retuned no primary root cause can be determined,the root cause will stay as a multi-factorial of the ones listed above.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that black spots were noticed inside the package.
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Search Alerts/Recalls
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