Catalog Number 383911 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2022 |
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 that the bd pegasus safety closed iv catheter system experienced leakage at the septum.This event occurred 7 times.The following information was provided by the initial reporter, translated from (b)(6): "after puncture, the steel needle was pulled out and blood was found leaking from the septum.".
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Event Description
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It was reported that the bd pegasus¿ safety closed iv catheter system experienced leakage at the septum.This event occurred 7 times.The following information was provided by the initial reporter, translated from chinese: "after puncture, the steel needle was pulled out and blood was found leaking from the septum.".
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Manufacturer Narrative
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In response to the event reported by the facility a device history review was conducted for lot number 2018791.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.Although photos were submitted for evaluation, the affected 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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Search Alerts/Recalls
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