Model Number 367364 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that foreign matter was found on a bd vacutainer ultratouch push button blood collection set during use.The following information was provided by the initial reporter: contaminated connecting pipe.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 12/28/2020.H6: investigation: bd received two (2) samples and one (1) photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for foreign matter with the incident lot was not observed as all product specifications were met.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.He most likely cause of the fm appears to be pallet dust.It is likely that the part was not pressed correctly between the center posts in the pallet and was able to hang off, getting trapped between two pallets and accumulating the dust.
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Event Description
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It was reported that foreign matter was found on a bd vacutainer® ultratouch¿ push button blood collection set during use.The following information was provided by the initial reporter: contaminated connecting pipe.
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Search Alerts/Recalls
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