Catalog Number 366408 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A sample is available for evaluation.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 prior to use it was discovered that the labels were falling off the tubes with a bd vacutainer® no additive (z) plus tubes.The following information was provided by the initial reporter: (6 of 7), it was reported that the labels are coming off the tubes.
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Manufacturer Narrative
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Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for label lift with the incident lot 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.Bd has initiated further investigation relating to this issue through a capa #1064141.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.
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Event Description
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It was reported that prior to use it was discovered that the labels were falling off the tubes with a bd vacutainer® no additive (z) plus tubes.The following information was provided by the initial reporter: (6 of 7).It was reported that the labels are coming off the tubes.
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Search Alerts/Recalls
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