Catalog Number UNKNOWN |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It has been reported that the unspecified bd¿ intima-ii has been found experiencing blood exposure during use.The following has been provided by the initial reporter: the nurse withdrew the needle core after the indwelling needle puncturing for the patient, and the needle brought out much blood which had contaminated hands of the nurse, there was no effect on the patient.
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Manufacturer Narrative
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H.6.Investigation summary unfortunately the provided lot number could not be validated in our systems, without a validated lot code our investigation team was unable to conduct a device history review.Similarly a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.
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Event Description
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It has been reported that the unspecified bd¿ intima-ii has been found experiencing blood exposure during use.The following has been provided by the initial reporter: the nurse withdrew the needle core after the indwelling needle puncturing for the patient, and the needle brought out much blood which had contaminated hands of the nurse, there was no effect on the patient.
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Search Alerts/Recalls
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