Model Number 366703 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/22/2019 |
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 an incorrect cap color was found after use with a bd vacutainer® no additive (z) tubes.The following information was provided by the initial reporter, "the tube cap was black.".
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Event Description
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It was reported that an incorrect cap color was found after use with a bd vacutainer® no additive (z) tubes.The following information was provided by the initial reporter, "the tube cap was black.".
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Manufacturer Narrative
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Investigation summary: bd received a contaminated samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for incorrect cap color with the incident lot was observed.Additionally, evaluation of the customer samples was performed, and incorrect cap color was observed.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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