Catalog Number 383083 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/26/2020 |
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 24gax0.75in prn ec slm npvc leaked.The following information was provided by the initial reporter: after the patient used the indwelling needle successfully.It was found that the prn was leaking.After replacing the screw cap, no such issue occurred and the liquid injected normally.
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Event Description
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It was reported that intima-ii y 24gax0.75in prn ec slm npvc leaked.The following information was provided by the initial reporter: after the patient used the indwelling needle sucessfully.It was found that the prn was leaking.After replacing the screw cap, no such issue occurred and the liquid injected normally.
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Manufacturer Narrative
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H.6.Investigation: a device history review was conducted for lot number 9323923.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 results of these show that the tested units 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.H3 other text : see h.10.
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Search Alerts/Recalls
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