Catalog Number ASK-05400-BW1 |
Device Problems
Break (1069); Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/06/2019 |
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 there were broken vials and the glass syringe stuck on locked position.
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Manufacturer Narrative
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Qn# (b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.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 lot number was not provided.A device history record review was performed based upon a lot number from sales history data.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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Event Description
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It was reported that there were broken vials and the glass syringe stuck on locked position.
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Search Alerts/Recalls
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