Catalog Number EDC-00820 |
Device Problems
Device Damaged Prior to Use (2284); Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The packaging expiration date did not match the sticker with the reported lot on it.The package was marked with the date 4/30/2021 and the sticker was marked 4/30/2020.They checked the stock, and no others were found.
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Event Description
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The packaging expiration date did not match the sticker with the reported lot' on it.The package was marked with the date (b)(6)2021 and the sticker was marked (b)(6)2020.They checked the stock, and no others were found.
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.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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Search Alerts/Recalls
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