Catalog Number AK-05502 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/14/2020 |
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 product was received with the outer box intact but when they opened the case they saw that the bottles of sodium chloride had broken, spilled, and evaporated on the trays, rendering them unusable.They reported 23f20a0137 as the lot number.
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Event Description
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It was reported that the product was received with the outer box intact but when they opened the case they saw that the bottles of sodium chloride had broken, spilled, and evaporated on the trays, rendering them unusable.They reported 23f20a0137 as the lot number.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the kit and saline solution ampule with a potentially relevant finding.For material # k-05500-042a (saline 10 ml solution), lot # 23p19l0271, according to incoming inspection records, 3 of 500 ampules were observed to have tips broken off in a batch of 43200.This is outside of the parameter for this defect.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.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 on the saline solution ampule.However, the potential cause of this complaint could not be determined based upon the information provided and without the sample.
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Search Alerts/Recalls
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