Catalog Number 383931 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2022 |
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.
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Event Description
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It was reported that the bd pegasus¿ safety closed iv catheter system had leakage at the connection site.The following information was provided by the initial reporter translated from chinese: "external leakage of blood and liquid was found at the arterial manometric connection of the patient, which was found to be caused by fracture at the interface of the closed blue needle puncture prevention vein indwelling needle.".
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Event Description
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It was reported that the bd pegasus¿ safety closed iv catheter system had leakage at the connection site.The following information was provided by the initial reporter translated from chinese: external leakage of blood and liquid was found at the arterial manometric connection of the patient, which was found to be caused by fracture at the interface of the closed blue needle puncture prevention vein indwelling needle.
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Manufacturer Narrative
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Investigation summary a device history review was conducted for lot number 0295605.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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Search Alerts/Recalls
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