Model Number 363083 |
Device Problem
Overfill (2404)
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Patient Problem
No Code Available (3191)
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Event Date 02/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.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 the bd vacutainer® buffered sodium citrate (9nc) blood collection tube had "too much" suction and overfilled during use.The patient had to be redrawn as a result.Medwatch report# mw5092606 was filed in response to this event.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: " bd vacutainer 2.7ml blue top tubes overfill.This causes the pt to have to be redrawn.The suction in the tube is too much and pulls too much blood.".
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Event Description
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It was reported that the bd vacutainer® buffered sodium citrate (9nc) blood collection tube had "too much" suction and overfilled during use.The patient had to be redrawn as a result.Medwatch report# mw5092606 was filed in response to this event.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: " bd vacutainer 2.7ml blue top tubes overfill.This causes the pt to have to be redrawn.The suction in the tube is too much and pulls too much 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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Search Alerts/Recalls
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