Catalog Number 383532 |
Device Problems
Disconnection (1171); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that the q-syte of the bd nexiva¿ closed iv catheter system separated during use and leaked blood all over the users uniform.The following information was provided by the initial reporter, translated from dutch: "when injecting the system, the qsite of the other t part flies off, leaving you as an introducer completely covered in blood.Normally the qsites on the nexiva needles are tight.This problem causes the caregiver to get covered in blood.Furthermore, you have to go change your uniform because you are covered in blood.The complaint was observed during commissioning of the product; it did not affect the patient.".
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Manufacturer Narrative
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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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Manufacturer Narrative
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H6.Investigation summary: since no 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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Event Description
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It was reported that the q-syte of the bd nexiva¿ closed iv catheter system separated during use and leaked blood all over the users uniform.The following information was provided by the initial reporter, translated from dutch: "when injecting the system, the qsite of the other t part flies off, leaving you as an introducer completely covered in blood.Normally the qsites on the nexiva needles are tight.This problem causes the caregiver to get covered in blood.Furthermore, you have to go change your uniform because you are covered in blood.The complaint was observed during commissioning of the product; it did not affect the patient.".
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Search Alerts/Recalls
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