Catalog Number 383078 |
Device Problem
Material Discolored (1170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that the end cap of the bd intima-ii¿ closed iv catheter system was discolored to yellow.The following information was provided by the initial reporter, translated from chinese: "intravenous infusion was performed.The nurse opened the indwelling needle package and found that the prn was yellow and oxidized.The indwelling needle was replaced immediately, and no adverse consequences were caused.".
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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 summary: a device history review was conducted for lot number 2082612.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 that the end cap of the bd intima-ii¿ closed iv catheter system was discolored to yellow.The following information was provided by the initial reporter, translated from chinese: "intravenous infusion was performed.The nurse opened the indwelling needle package and found that the prn was yellow and oxidized.The indwelling needle was replaced immediately, and no adverse consequences were caused.".
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Search Alerts/Recalls
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