Catalog Number 364815 |
Device Problems
Fluid/Blood Leak (1250); Volume Accuracy Problem (1675); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2022 |
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.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® one use holder, the customer stated the holder would not thread which lead to leak and underfill.The following information was provided by the initial reporter.The customer stated: it was reported that the holder will not thread all the way flush.Customer says when threading holder onto the back of the push button ultratouch wing set, the holder will not thread all the way flush and there's a gap between the top of the holder and the hub of the wing set.This is causing the bd vacutainer tubes to underfill and in some cases, blood is leaking into the holder.
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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.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® one use holder, the customer stated the holder would not thread which lead to leak and underfill.The following information was provided by the initial reporter.The customer stated: it was reported that the holder will not thread all the way flush.Customer says when threading holder onto the back of the push button ultratouch wing set, the holder will not thread all the way flush and there's a gap between the top of the holder and the hub of the wing set.This is causing the bd vacutainer tubes to underfill and in some cases, blood is leaking into the holder.
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Event Description
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It was reported when using the bd vacutainer® one use holder, the customer stated the holder would not thread which lead to leak and underfill.The following information was provided by the initial reporter.The customer stated: it was reported that the holder will not thread all the way flush.Customer says when threading holder onto the back of the push button ultratouch wing set, the holder will not thread all the way flush and there's a gap between the top of the holder and the hub of the wing set.This is causing the bd vacutainer tubes to underfill and in some cases, blood is leaking into the holder.
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Manufacturer Narrative
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H6: investigation summary no samples or photos were returned by the customer in support of this complaint.Lot number is unknown.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because no samples or photos were returned, and lot number is unknown.Lot number is unknown; therefore, no retention samples are available.The device history records could not be reviewed as the lot number is unknown.
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Search Alerts/Recalls
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