Model Number 57417 |
Device Problems
Nonstandard Device (1420); Device Misassembled During Manufacturing /Shipping (2912)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/28/2015 |
Event Type
malfunction
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Event Description
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Medtronic received information that while connecting this cannula to their perfusion circuit, the customer observed that the barbs on the 3/8 connector were oriented in the wrong direction.This made the cannula very difficult to connect.There were no adverse patient effects as a result of the event.
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Manufacturer Narrative
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The device was discarded by the customer and was not returned for analysis.Review of devices from this lot showed the barbs on the connector to be in the wrong orientation.Preliminary investigation suggests that the root cause is related to an insert placed in the reverse orientation during the manufacturing process.Patient information has been requested, but has not been provided to medtronic.(b)(4).
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Manufacturer Narrative
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While this specific cannula was not available for analysis, others from the same lot were evaluated.Medtronic's investigation confirmed that the root cause was confirmed to be a reversed insert in the injection molding process of the cannula connector at the injection molding supplier.Corrective actions were taken to prevent future recurrence of the issue.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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