Model Number 989803137631 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/18/2021 |
Event Type
Injury
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Event Description
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The customer reported that fse went missing and was found on the newborn's head.The customer also stated there was no abnormality in the newborn patient after removal of the needle.
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Manufacturer Narrative
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The device was returned and evaluated by the supplier.The compliant was confirmed, upon receipt of the device the needle was found to be broken apart from he electrode hub.The failure was determined to be most likely due to user error the failure was determined to be most likely due to user error.The customer was provided information and the device was scrapped.No further actions were taken and none are warranted.
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Event Description
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The customer reported that fse went missing and was found on the newborn's head.The customer also stated there was no abnormality in the newborn patient after removal of the needle.
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Search Alerts/Recalls
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