BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 368836 |
Device Problem
Premature Separation (4045)
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Patient Problem
Discomfort (2330)
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Event Date 08/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.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 when using the bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder malfunctions when taking samples, leaving the needle exposed without the holder when drawing blood.Patient 3 of 3.The following information was provided by the initial reporter.The customer stated: from the customer: after we stick a patient, the sleeve itself has come off the needle and the needle is left in the patient's arm with the needle perforating the test tubes exposed without the sleeve protecting it.This has happened on three separate occasions and for three different test takers.When examining two of the sleeves, it looks like the plastic sleeves have cracked on the side where they attach to the needles.We have now taken all needles with the same lot no.Out of order.
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Manufacturer Narrative
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D10: device available for eval: yes.D10: returned to manufacturer on: 17-oct-2023.H6.Investigation summary: bd received 560 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for holder breaks off with the incident lot was not observed.Additionally, 10 of the returned samples along with 10 retention samples from bd inventory were evaluated by functional testing, each used to draw 6 vacutainer tubes, and no issues were observed relating to holder breaks off as all samples met specifications.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.This complaint is unable to be confirmed for the indicated failure mode holder breaks off.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported when using the bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder malfunctions when taking samples, leaving the needle exposed without the holder when drawing blood.Patient 3 of 3.The following information was provided by the initial reporter.The customer stated: from the customer: after we stick a patient, the sleeve itself has come off the needle and the needle is left in the patient's arm with the needle perforating the test tubes exposed without the sleeve protecting it.This has happened on three separate occasions and for three different test takers.When examining two of the sleeves, it looks like the plastic sleeves have cracked on the side where they attach to the needles.We have now taken all needles with the same lot no.Out of order.
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Search Alerts/Recalls
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