Catalog Number 401622 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/19/2020 |
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.
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Event Description
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It was reported that anesthesia 17gax18cm durasafe leaked during use.The following information was provided by the initial reporter: when anesthesiologists used epidural catheters, the medicine was injected after catheterization, there was leakage at the syringe joint of the catheters, it was resulting in the leakage of the liquid and there was the gap of the dose.
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Manufacturer Narrative
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Investigation summary a device history review was conducted for lot number 9046560.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.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue and encourages you to submit your sample for review.
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Event Description
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It was reported that anesthesia 17gax18cm durasafe leaked during use.The following information was provided by the initial reporter: when anesthesiologists used epidural catheters, the medicine was injected after catheterization, there was leakage at the syringe joint of the catheters, it was resulting in the leakage of the liquid and there was the gap of the dose.
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Search Alerts/Recalls
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