Catalog Number 383687 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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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 that the blood sample collected from the bd nexiva¿ closed iv catheter system hemolyzed.The following information was provided by the initial reporter, translated from italian: "the pharmacy.Reports hemolysis problems of blood samples taken from nexiva 18 and 20g with the bd vacutainer system." "the reporting of hemolysis of the samples takes place from different departments that welcome patients for admissions to be subjected to hemodynamic, electrophysiology and cardiac surgery.These patients are placed the nexiva in a special admission service where, immediately after placement, routine samples are taken.The sampling takes place immediately after placement, first having the blood filled with blood extension and connecting the bd vacutainer vacuum collection system after removing the cap with hydrophobic membrane.The withdrawal is not done from the side port or from the q syte.".
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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 that the blood sample collected from the bd nexiva¿ closed iv catheter system hemolyzed.The following information was provided by the initial reporter, translated from (b)(6): "the pharmacy.Reports hemolysis problems of blood samples taken from nexiva 18 and 20g with the bd vacutainer system." "the reporting of hemolysis of the samples takes place from different departments that welcome patients for admissions to be subjected to hemodynamic, electrophysiology and cardiac surgery.These patients are placed the nexiva in a special admission service where, immediately after placement, routine samples are taken.The sampling takes place immediately after placement, first having the blood filled with blood extension and connecting the bd vacutainer vacuum collection system after removing the cap with hydrophobic membrane.The withdrawal is not done from the side port or from the q syte.".
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Event Description
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It was reported that the blood sample collected from the bd nexiva¿ closed iv catheter system hemolyzed.The following information was provided by the initial reporter, translated from italian: "the pharmacy.Reports hemolysis problems of blood samples taken from nexiva 18 and 20g with the bd vacutainer system." "the reporting of hemolysis of the samples takes place from different departments that welcome patients for admissions to be subjected to hemodynamic, electrophysiology and cardiac surgery.These patients are placed the nexiva in a special admission service where, immediately after placement, routine samples are taken.The sampling takes place immediately after placement, first having the blood filled with blood extension and connecting the bd vacutainer vacuum collection system after removing the cap with hydrophobic membrane.The withdrawal is not done from the side port or from the q syte.".
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Manufacturer Narrative
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H6: investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Search Alerts/Recalls
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