Catalog Number 391350 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Hypoglycemia (1912)
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Event Date 09/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that during use, the neonatal medical team was not able to place a cannula due to difficult cannula insertion.The baby¿s blood glucose dropped to an unsafe level during attempts.The infant who was involved in this incident will be followed up as an outpatient to determine the effects of this incident with low blood glucose.A bolus of dextrose was administered as medical intervention.
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Manufacturer Narrative
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No return sample for investigation.The nonconformance cannot be confirmed as no sample was returned for investigation.Thus, no root cause can be determined.The complaint will be re-opened if the sample is returned for investigation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7076167.A manufacturing review also revealed no abnormalities that could have influenced the reported issue.Capa # (b)(4) was issued to review the tubing material.
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Search Alerts/Recalls
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