BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE
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Model Number 367352 |
Device Problem
Break (1069)
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Patient Problem
Bruise/Contusion (1754)
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Event Date 12/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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® push button blood collection set with pre-attached holder has been found with the cannula breaking off during use.The following has been provided by the initial reporter: it is reported needle broke during blood collection.Verbiage received, - bd vacutainer set with reattached holder containing 21g x 3/4 inch x 12 inch butterfly attachment lot #8323548, exp 11/30/2020: during venipuncture the needle (metal portion) broke off and had to be retrieved from entrance to vein with forceps.Metal portion of vacutainer removed intact.Pt had brief syncopal response to this event.Pt declined ultrasound to assess for any remaining foreign body.Pt reports no symptoms other than mild bruise at site of veinpuncture, states that he feels well on f/u call.Product discarded into sharps container at the time of the event.
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Manufacturer Narrative
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H.6.Investigation: bd received samples from the customer facility for investigation.The samples were tested and the customer's indicated failure mode for breaks off 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.
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Event Description
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It has been reported that one bd vacutainer® push button blood collection set with pre-attached holder has been found with the cannula breaking off during use.The following has been provided by the initial reporter: it is reported needle broke during blood collection.Verbiage received, bd vacutainer set with reattached holder containing 21g x 3/4 inch x 12 inch butterfly attachment lot #8323548, exp 11/30/2020: during venipuncture the needle (metal portion) broke off and had to be retrieved from entrance to vein with forceps.Metal portion of vacutainer removed intact.Pt had brief syncopal response to this event.Pt declined ultrasound to assess for any remaining foreign body.Pt reports no symptoms other than mild bruise at site of veinpuncture, states that he feels well on f/u call.Product discarded into sharps container at the time of the event.
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Search Alerts/Recalls
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