Catalog Number AM-05501 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/31/2020 |
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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The report states: anesthesia technician notified me this morning of reports from the ob director of 2 kits from same lot with broken vials.
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Manufacturer Narrative
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(b)(4).A device history record review was performed based on potential lot numbers (23f19d0087 and 23f19d0007) provided by the customer.Lot number 23f19d0087 is for kit cdc-45703-xp1a so the device history record review was performed for lot number 23f19d0007.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 based on a potential lot number provided by the customer.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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The report states: anesthesia technician notified me this morning of reports from the ob director of 2 kits from same lot with broken vials.
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Search Alerts/Recalls
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