Model Number 381433 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: unknown.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 prior to use the needle was discovered to not be in sterile packaging with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter: one of the needles wasn't in its sterile package but was sterilized crossways on the other needles.
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Manufacturer Narrative
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H.6.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that prior to use the needle was discovered to not be in sterile packaging with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter: one of the needles wasn't in its sterile package but was sterilized crossways on the other needles.
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Search Alerts/Recalls
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