Model Number 364956 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported when using the bd vacutainer® urine complete cup kit there was sample leakage.The following information was provided by the initial reporter.The customer stated: there was "intermittent leaking of a specimen despite lid tightly closed.There was no exposure or medical interventions.The leakage came from the lid and the specimen was transported in a plastic specimen bag.".
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Manufacturer Narrative
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H.6.Investigation: 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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Event Description
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It was reported when using the bd vacutainer® urine complete cup kit there was sample leakage.The following information was provided by the initial reporter.The customer stated: there was "intermittent leaking of a specimen despite lid tightly closed.There was no exposure or medical interventions.The leakage came from the lid and the specimen was transported in a plastic specimen bag.".
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Search Alerts/Recalls
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