Catalog Number 0250070500 |
Device Problems
Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that there was foreign material inside the sterile packaging.
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Event Description
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It was reported that there was foreign material inside the sterile
packaging.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: black spot found on inside of the box probable root cause: "1.Manufacturing/assembly/ service error.2.Incorrect or inadequate packaging.3.Severe shipping conditions.4.User error: 110, 130, 140".Manufacture date is not known.
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Search Alerts/Recalls
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