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Catalog Number 9734300 |
Device Problems
Complete Blockage (1094); Occlusion Within Device (1423); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/25/2014 |
Event Type
malfunction
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Event Description
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A medtronic representative received a report that, while in sterile processing at a site, a solera tap was discovered to have bone stuck in the cannulated portion of the tap.The site representatives could not remove the material from the tap.No further details were provided.There was no patient present when this issue was identified.
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Manufacturer Narrative
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No patient information provided as no patient was involved in this concern.Device lot number, or serial number, not available.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Rma issued.Replacement 5.5 solera tap shipped to site (b)(4) 2014.A medtronic representative, following-up at the site, reported a site representative from sterile processing department stated the suspect 5.5 solera tap was discarded by the site at the time of the event.Part not returned to manufacturer.
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Manufacturer Narrative
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Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.
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Search Alerts/Recalls
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