Catalog Number 364943 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.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 bd vacutainer® urinalysis transfer straw kit experienced use after the expiration date.The following information was provided by the initial reporter: material no.364943, batch no.6340866.The product was received expired and it was used.The lab noticed the product was expired.Date of event is unknown.
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Manufacturer Narrative
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Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the bd vacutainer® urinalysis transfer straw kit experienced use after the expiration date.The following information was provided by the initial reporter: material no.364943 batch no.6340866.The product was received expired and it was used.The lab noticed the product was expired.Date of event is unknown.
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Search Alerts/Recalls
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