Model Number CNO11 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The event unit returned for evaluation.A follow-up report will be provided upon completion of investigation.
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Event Description
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Name of procedure being performed: na (incoming inspection).Detailed description of event: the product did not pass the incoming inspection of po#19-02app because of torn packaging.Details are shown on the attached file.Type of intervention: na.Patient status: no patient involved.
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Event Description
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Name of procedure being performed: na (incoming inspection).Detailed description of event: the product did not pass the incoming inspection of po#: (b)(4) because of torn packaging.Type of intervention: na.Patient status: no patient involved.
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering observed minor creases and scuffs on the c-film side of the pouch.Engineering also confirmed that there was a hole in the tyvek of the pouch.Based on the condition of the returned unit, the reported event was caused by the interaction between the tray edge and the pouch.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
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Search Alerts/Recalls
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