Catalog Number 383028 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Blood Loss (2597)
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Event Date 04/23/2019 |
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.
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system leaked blood during the puncture.The following information was provided by the initial reporter, translated from (b)(6) to english: "it was found blood leakage during puncture.".
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system leaked blood during the puncture.The following information was provided by the initial reporter, translated from chinese to english: "it was found blood leakage during puncture.".
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Manufacturer Narrative
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Investigation: a device history review was conducted for lot number 8171177.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.Unfortunately a sample could not be obtained for evaluation and testing.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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