Catalog Number 383012 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 6 bd intima-ii¿ closed iv catheter systems experienced foreign matter contamination.The following information was provided by the initial reporter: from december 1st to december 11th, the nurse found flocculation near the front of the catheter tube before vein puncture to the patient.
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Manufacturer Narrative
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H.6.Investigation: a device history review was conducted for lot number 9077608.Our records show that this is the only instance of this issue occurring in this production batch.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.Although photos were submitted for evaluation, the affected device could not be returned; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to test the composition of the foreign materiel, our quality engineers were unable to determine the root cause for this complaint.
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Event Description
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It was reported that 6 bd intima-ii¿ closed iv catheter systems experienced foreign matter contamination.The following information was provided by the initial reporter: from december 1st to december 11th, the nurse found flocculation near the front of the catheter tube before vein puncture to the patient.
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Search Alerts/Recalls
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