Catalog Number 383012 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2021 |
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.(b)(4).
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Event Description
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It was reported that intima-ii y 20gax1.16in prn/ec slm had foreign matter.The following information was provided by the initial reporter: when the closed vein indwelling needle was used in the puncture room of the first ct room , the new package of 20g indwelling needle no.383012 was opened, and multiple stains and rust were found on the needle hub and rubber plug.
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Event Description
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It was reported that intima-ii y 20gax1.16in prn/ec slm had foreign matter.The following information was provided by the initial reporter: when the closed vein indwelling needle was used in the puncture room of the first ct room , the new package of 20g indwelling needle no.383012 was opened, and multiple stains and rust were found on the needle hub and rubber plug.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-05 h6: investigation summary a device history review was conducted for lot number 0267245.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, composition testing was performed on the returned sample, allowing our engineers to positively associate it with the manufacturing process.Based on their review the most likely source of this material is residue from the injection molding process.H3 other text : see h10.
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Search Alerts/Recalls
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