Catalog Number 367324 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Results: bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for unsealed packaging with the incident lot was observed.Conclusion: based on the investigation, the root cause / potential root cause for the unsealed package was determined to be that this unit was inadvertently not rejected by the operator at the packaging station.
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Event Description
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It was reported that 23 g x.75 in.Bd vacutainer® winged safety push button blood collection set with 12 in.Tubing was not sealed in the packaging.No injury or medical intervention.
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Manufacturer Narrative
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A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.
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Search Alerts/Recalls
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