Catalog Number MTO-09801-CHA |
Device Problems
Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/14/2019 |
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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The customer reports: when the tray was opened, it was cracked and broken.
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Manufacturer Narrative
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(b)(4).The customer returned one semi-opened psi kit for analysis.Visual inspection revealed that the bottom right corner of lidstock was partially opened.A piece of the tray had broken off and was still attached to the lidstock.A crack was also observed near the broken section of the tray.No signs of use were identified in the kit contents.A device history record review was performed and no relevant findings were identified to indicate a manufacturing related cause.The customer complaint of a damaged tray was confirmed through complaint investigation of the returned sample.Visual examination revealed that the kit was partially opened, and a portion of the tray had broken off and was still attached to the lidstock.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.Based on the sample received and the customer description, the root 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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The customer reports: when the tray was opened, it was cracked and broken.
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Search Alerts/Recalls
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