Catalog Number 367283 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
Bruise/Contusion (1754)
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Event Date 08/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 has been reported that one bd vacutainer® safety-lok¿ blood collection set has been found experiencing insufficient blood flow during use.The following has been provided by the initial reporter: it was reported that facility is having issues with the butterfly needles.Having to stick patients twice, patients are bruising, vein blows, no flashback, not flowing good.
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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.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to insufficient blood flow as all samples met specifications.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.H3 other text : see h.10.
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Event Description
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It has been reported that one bd vacutainer® safety-lok¿ blood collection set has been found experiencing insufficient blood flow during use.The following has been provided by the initial reporter: it was reported that facility is having issues with the butterfly needles.Having to stick patients twice , patients are bruising, vein blows, no flashback, not flowing good.
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Search Alerts/Recalls
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