Catalog Number 004551003 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.
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Event Description
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Customer complaint alleges "physician pulled blade to utilize in practice and found plastic to be broken within packaging." it is unclear if the alleged defect was detected in a clinical setting.It was reported there was no patient involvement.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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Customer complaint alleges "physician pulled blade to utilize in practice and found plastic to be broken within packaging." it is unclear if the alleged defect was detected in a clinical setting.It was reported there was no patient involvement.
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Search Alerts/Recalls
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