Catalog Number 383012 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2021 |
Event Type
malfunction
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Event Description
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It was reported bd intima ii iv catheter had foreign matter in the needle area.The following information was provided by the initial reporter, translated from (b)(6): "foreign bodies were found in the needle area of the product when used for patients.".
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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.
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Manufacturer Narrative
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H6: investigation: a device history review was conducted for lot number 0063904.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.A sample could not be obtained for evaluation and testing; 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 investigate the affected unit 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 bd intima ii iv catheter had foreign matter in the needle area.The following information was provided by the initial reporter, translated from chinese: "foreign bodies were found in the needle area of the product when used for patients.".
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Search Alerts/Recalls
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