Catalog Number AJ-09903 |
Device Problems
Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/21/2019 |
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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Preliminary investigation confirmed that sample received has scratch marks on the bottom of the tray that matched the customer complaint.However, during that same preliminary investigation, a sterility issue was also observed on the corner of the same tray.
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Manufacturer Narrative
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Qn#(b)(4).The customer returned one opened psi kit for analysis.Visual examination revealed a small crack in the corner of the tray.White stress marks were identified on all four corners of the tray.Although the tray was previously opened, the tray flange contained evidence of proper sealing.A device history record review was performed, and no relevant findings were identified.The report of a sterility issue was confirmed through complaint investigation.Visual analysis revealed that the bottom-left corner of the tray was cracked.A device history record review was performed, and no relevant findings were identified.Based on the customer description and the sample received, design caused or contributed to this event.A non-conformance request was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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Preliminary investigation confirmed that sample received has scratch marks on the bottom of the tray that matched the customer complaint.However, during that same preliminary investigation, a sterility issue was also observed on the corner of the same tray.
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Search Alerts/Recalls
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