Catalog Number 383055 |
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 09/14/2021 |
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 bd intima ii plus¿ iv catheter had foreign, yellow discoloration on the inner top web of its packaging.The following information was provided by the initial reporter, translated from chinese to english: "in fifth ward of gynecology, there was yellow foreign matter on the outside of the product when the package was opened".
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Event Description
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It was reported that the bd intima ii plus¿ iv catheter had foreign, yellow discoloration on the inner top web of its packaging.The following information was provided by the initial reporter, translated from chinese to english: "in fifth ward of gynecology, there was yellow foreign matter on the outside of the product when the package was opened".
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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: 2021-09-29.Investigation summary: a device history review was conducted for lot number 0322695.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, an opened packaging unit was submitted to our facility.Our engineers were able to identify the brown foreign matter and submitted the material for composition testing.The foreign material was identified as fumaric acid.This material is not present on the manufacturing floor.Due to these observations and the breached seal of the packaging unit our engineers were not able to associate the root cause for this complaint with the manufacturing process.H3 other text : see h10.
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Search Alerts/Recalls
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