Catalog Number 401622 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2021 |
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 had foreign matter.The following information was provided by the initial reporter: the department of anesthesiology.Foreign matter were found during use.
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Event Description
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It was reported that anesthesia 17gax18cm durasafe had foreign matter.The following information was provided by the initial reporter: the department of anesthesiology.Foreign matter were found during use.
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Manufacturer Narrative
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H6: investigation summary: a device history review was conducted for lot number 0255551.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.Additionally, the sample submitted by your facility, was subjected to functional testing, by our team of quality engineers.Results of this testing were able to positively identify the foreign material as cotton residue from the cutting and folding process.The presence of this material is controlled by the manual removal by the manufacturing operator.H3 other text : see h10.
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Search Alerts/Recalls
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