Catalog Number 383033 |
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 10/08/2020 |
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.Fda device problem code: 2944.Fda patient problem code: 2645.
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Event Description
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It was reported that rust was found on the bd intima-ii¿ closed iv catheter system needle.The following information was provided by the initial reporter, translated from chinese to english: "on october 8, 2020, when preparing to puncture the intravenous indwelling needle for the patient, the needle was found to have rust when the needle cap was removed for exhausting air.The intravenous indwelling needle was immediately replaced and no harm was caused 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 9077842.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 rust was found on the bd intima-ii¿ closed iv catheter system needle.The following information was provided by the initial reporter, translated from chinese to english: "on (b)(6), 2020, when preparing to puncture the intravenous indwelling needle for the patient, the needle was found to have rust when the needle cap was removed for exhausting air.The intravenous indwelling needle was immediately replaced and no harm was caused to the patient.".
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Search Alerts/Recalls
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