Catalog Number 383319 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2021 |
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.(b)(4).
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Event Description
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It was reported that the bd saf-t-intima¿ iv catheter safety system experienced foreign matter in or on device cannula/needle/catheter.The following information was provided by the initial reporter: material no.: 383319 batch no.: 0171902 found a lint on needle before insertion.Needle discarded by denise.
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Event Description
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It was reported that the bd saf-t-intima¿ iv catheter safety system experienced foreign matter in or on device cannula/needle/catheter.The following information was provided by the initial reporter: material no.: 383319 batch no.: 0171902 found a lint on needle before insertion.Needle discarded by denise.
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Manufacturer Narrative
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H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 0171902.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.This is the first complaint for foreign matter on material 383319 & batch 0171902.See h.10.
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Search Alerts/Recalls
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