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Catalog Number 368652 |
Device Problems
Fluid/Blood Leak (1250); Cut In Material (2454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7185858.Medical device expiration date: 2019-07-31.Device manufacture date: 2017-08-03.Medical device lot #: 7185859.Medical device expiration date: 2019-07-31.Device manufacture date: 2017-08-03.Initial reporter phone#: (b)(6).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 during use, a bd vacutainer® push button blood collection set was found with ¿cuts in the tubing¿.This resulted in blood leaking out of tubing while performing a blood draw.There was no report of injury or medical intervention reported.
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Manufacturer Narrative
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Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Bd has initiated further investigation relating to this issue through a capa.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.A review of the device history record was completed for this batch.Product was manufactured at the bd (b)(4) site july-2017.Product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections.All inspections were in compliance with requirements.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.However, further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: although no samples or photos were available for evaluation, bd has initiated further investigation through a capa to identify the potential root cause(s).Capa# (b)(4).
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Search Alerts/Recalls
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