Catalog Number 383078 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2022 |
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 bd intima-ii 24gax0.75in prn slm npvc had leakage issues.The following information was provided by the initial reporter: "when the indwelling needle was removed to connect the scalp needle to exhaust, fluid leakage was found in the extension tube of the indwelling needle, and the indwelling needle was replaced for infusion.".
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Manufacturer Narrative
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H6: investigation summary: a device history review was conducted for lot number 1320178.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.
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Event Description
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It was reported bd intima-ii 24gax0.75in prn slm npvc had leakage issues.The following information was provided by the initial reporter: "when the indwelling needle was removed to connect the scalp needle to exhaust, fluid leakage was found in the extension tube of the indwelling needle, and the indwelling needle was replaced for infusion.".
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Search Alerts/Recalls
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