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Model Number H965SCH505110 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the device became contaminated during unpacking.During unpacking of a 6.0-80, 80 (b)(6) balloon catheter, when the box was opened, 'the balloon exited immediately' from the package and it was desterilized.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.Received for analysis was the outer box, inner packaging and the wanda balloon catheter.The outer box was torn open.No other damage was present.The wanda device was free moving in the opened inner packaging.The inner tray was not returned for analysis.An examination of the balloon catheter identified no issues.There was no evidence of any device use.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
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Event Description
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It was reported that the device became contaminated during unpacking.During unpacking of a 6.0-80, 80 wanda balloon catheter, when the box was opened, 'the balloon exited immediately' from the package and it was desterilized.No patient complications were reported.
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Search Alerts/Recalls
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