Catalog Number 364815 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: 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 needle of the bd vacutainer® single use holder detached from the holder during use.No reports of serious injury or medical intervention noted.
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Manufacturer Narrative
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Investigation summary: bd received samples from the customer facility for investigation.The samples were tested and the customer's indicated failure mode for separation with the incident lot was not observed as all product specifications were met.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.Based on evaluation of the customer samples, the customer¿s indicated failure mode for separation with the incident lot was not observed as all samples met the required specifications.Based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.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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Manufacturer Narrative
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Investigation summary: bd received samples from the customer facility for investigation.The samples were tested and the customer's indicated failure mode for separation with the incident lot was not observed as all product specifications were met.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.Based on evaluation of the customer samples, the customer¿s indicated failure mode for separation with the incident lot was not observed as all samples met the required specifications.Based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.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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Search Alerts/Recalls
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