Model Number 367989 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Blood Loss (2597)
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Event Date 01/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd vacutainer® sst¿ blood collection tubes leaked.The following information was provided by the initial reporter: "blood leaked from the connection of the shield and the stopper.".
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Event Description
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It was reported that bd vacutainer® sst¿ blood collection tubes leaked the following information was provided by the initial reporter: "blood leaked from the connection of the shield and the stopper.".
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.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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