Model Number 383532 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2022 |
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 that the needle of the bd nexiva¿ closed iv catheter system was much longer than the listed label specifications.The following information was provided by the initial reporter: "customer said they took the nexiva catheter out of the package and it looked much longer than the 1 inch needle that was supposed to be inside.".
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Event Description
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It was reported that the needle of the bd nexiva¿ closed iv catheter system was much longer than the listed label specifications.The following information was provided by the initial reporter: "customer said they took the nexiva catheter out of the package and it looked much longer than the 1 inch needle that was supposed to be inside.".
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Manufacturer Narrative
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H6: investigation summary: the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review could not be performed as the lot number was not clearly visible in the photograph provided.
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Search Alerts/Recalls
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