Model Number 3600-100 |
Device Problem
Defective Component (2292)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be submitted upon completion of the investigation into this event.
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Event Description
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Received a report that the drain came out of the package with a defective suction nozzle.
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Manufacturer Narrative
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The sample has been received and a follow up report will be submitted upon the completion of the investigation.
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Manufacturer Narrative
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The oasis chest drain was returned and removed from the large bio-hazard bag that the drain was packaged in.Upon opening the bag it was clear that the blue suction nozzle had been struck at some point after being shipped to the institution.Damage of this nature would have very easily been recognized by the manufacturing operator.The drain otherwise was in good condition.There were no other signs of damage.The box that the drain was shipped in from the factory was not returned.During the process of manufacture the operator conducts a 100% visual and tactile inspection of the welded vacuum nozzle to ensure it was properly welded in place.If the nozzle would have been damaged it would have been noticed during the inspection process.A review of the device history records and incoming inspection records of the oasis chest drain were conducted to ensure they met all quality and performance requirements and that there were no non-conformances during the manufacturing build.Summary/conclusion - based on the investigation atrium medical corporation cannot conclude that the nozzle was damaged at the site of manufacture.It is likely the nozzle was damaged either in transit or after it was removed from the package at the institution.
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Search Alerts/Recalls
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