Catalog Number 383012 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
Blood Loss (2597)
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Event Date 05/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that intima-ii y 20 ga x 1.16 in prn/ec slm leaked at the catheter junction.This was discovered during use.The following information was provided by the initial reporter: the connection between the needle and the indwelling needle was broken, and the patient suffered slight bleeding.A new indwelling needle was replaced after treatment.
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Manufacturer Narrative
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H.6.Investigation summary a device history review was conducted for lot number 9239029.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, functional testing was performed on retention samples for this lot.The units were performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.See h.10.
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Event Description
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It was reported that intima-ii y 20gax1.16in prn/ec slm leaked at the catheter junction.This was discovered during use.The following information was provided by the initial reporter: the connection between the needle and the indwelling needle was broken, and the patient suffered slight bleeding.A new indwelling needle was replaced after treatment.
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Search Alerts/Recalls
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