Catalog Number ASK-03000-MN |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The kit 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 the new trays are not keeping items in order and breaking vials.When they signed the contract for the custom kit, they did not sign for the same outer tray that is being sent.They want they soft trays replaced with the sturdy plastic tray they signed up for.
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Event Description
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It was reported that the new trays are not keeping items in order and breaking vials.When they signed the contract for the custom kit, they did not sign for the same outer tray that is being sent.They want they soft trays replaced with the sturdy plastic tray they signed up for.
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Manufacturer Narrative
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Qn# (b)(4).A device history record review was performed with a potentially relevant finding.A nonconformance was initiated only as a general nc to temporarily allow certain finished good part numbers to be packaged with additional gauze in order to better secure medication ampules in the inner tray.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 capa was initiated to further investigate this complaint issue.
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Search Alerts/Recalls
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