Catalog Number 383083 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: (b)(6).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 the bd intima-ii¿ closed iv catheter system experienced foreign matter on the device cannula.The following information was provided by the initial reporter, translated from chinese: there is a white unidentified substance on one side of the disposable infusion connector.
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system experienced foreign matter on the device cannula.The following information was provided by the initial reporter, translated from chinese: there is a white unidentified substance on one side of the disposable infusion connector.
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Manufacturer Narrative
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H6: investigation summary: in response to the event reported a device history review was conducted for lot number 2011049.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Search Alerts/Recalls
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