Model Number 367364 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Blood Loss (2597)
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Event Date 04/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: jka, fpa.Common device name: blood specimen collection device; intravascular administration set.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 during use blood leakage occurred with a bd vacutainer® ultratouch¿ push button blood collection set.The following information was provided by the initial reporter: it was reported customer experienced leaking when using wingset.Noticed blood collecting outside of the needle oozing down the tubing.Noticed that the needle collection chamber was full of blood.
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Manufacturer Narrative
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H.6.Investigation: 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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Event Description
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It was reported that during use blood leakage occurred with a bd vacutainer® ultratouch¿ push button blood collection set.The following information was provided by the initial reporter: it was reported customer experienced leaking when using wingset.Noticed blood collecting outside of the needle oozing down the tubing.Noticed that the needle collection chamber was full of blood.
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Search Alerts/Recalls
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