Catalog Number 401622 |
Device Problems
Component Incompatible (1108); Misconnection (1399)
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Patient Problem
No Information (3190)
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Event Date 04/10/2019 |
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 anesthesia 17gax18cm durasafe experienced incompatible components.The following information was provided by the initial reporter: after opening the unit package, it was found that the epidural catheter connector could not be connected with the sip tip syringe.Opening one new product,the new epidural catheter connector can connected to the sip tip syringe.
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Event Description
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It was reported that the anesthesia 17gax18cm durasafe experienced incompatible components.The following information was provided by the initial reporter: after opening the unit package, it was found that the epidural catheter connector could not be connected with the sip tip syringe.Opening one new product,the new epidural catheter connector can connected to the sip tip syringe.
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Manufacturer Narrative
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Investigation: a device history review was conducted for lot number 8232456 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.Additionally, our quality engineers reviewed the device provided by your facility, and founded device to be qualified by the standards set by production specifications.Unfortunately without being able to review the reported failure mode, the root cause could not be determined at the conclusion of our review.
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Search Alerts/Recalls
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