Catalog Number AK-05560 |
Device Problem
Break (1069)
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Patient Problem
Not Applicable (3189)
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Event Date 01/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that each of the trays was found to have broken lidocaine ampules.There was no injury.
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Event Description
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It was reported that each of the trays was found to have broken lidocaine ampules.There was no injury.
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Manufacturer Narrative
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(b)(4).A device history record review was performed with a potentially relevant finding.Nonconformance 40010488 was initiated to address broken ampule issues for lot# 23f18k0787.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed with a potentially relevant finding.Based on the information provided, the potential root cause of this issue is design related.A nonconformance was initiated to further investigate this complaint issue.
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Search Alerts/Recalls
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