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 07/25/2022 |
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 while using the bd pegasus¿ safety closed iv catheter system that blood was leaking from the septum.The following information was provided by the initial reporter, translated from chinese: the head nurse of neurology department punctured the patient and pulled out the steel needle and found that blood was leaking from the septum.
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Manufacturer Narrative
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Investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 2018791.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.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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Event Description
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It was reported that while using the bd pegasus¿ safety closed iv catheter system that blood was leaking from the septum.The following information was provided by the initial reporter, translated from chinese: the head nurse of neurology department punctured the patient and pulled out the steel needle and found that blood was leaking from the septum.
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Search Alerts/Recalls
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