Catalog Number 306572 |
Device Problem
Short Fill (1575)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the syringe 10ml saline xs experienced an incorrect fill -less than design specifications.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 306572 batch no.: 9224747.Per email: physician preparing for line insertion opened the packaging for a sterile prefilled 10cc ns syringe.Immediately observed that the syringe contained <2cc ns.
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Event Description
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It was reported that the syringe 10ml saline xs experienced an incorrect fill -less than design specifications.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 306572 batch no.: 9224747.Per email: physician preparing for line insertion opened the packaging for a sterile prefilled 10cc ns syringe.Immediately observed that the syringe contained <2cc ns.
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Manufacturer Narrative
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H.6.Investigation: a device history record review was completed for provided lot number 9224747 and the review did not reveal any detected quality issues that could have contributed to this reported incident.To further investigate this issue, one picture sample was provided for evaluation by our quality engineer.Through examination of the provided picture, the syringe was observed to be incorrectly filled.Based on the returned picture alone, it is unclear what the exact cause of the incorrect fill may have been; therefore, a manufacturing related cause could not be determined for this incident.
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Search Alerts/Recalls
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