Catalog Number 300296 |
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 04/07/2021 |
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 discardit¿ ii 20 ml syringe experienced foreign matter in the fluid path.The following information was provided by the initial reporter: dispensing, white flocs are found in the syringe.
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Manufacturer Narrative
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Investigation summary: no photos or samples were received by our quality team for evaluation.The team has evaluated twenty retained samples of the reported lot and no defect was observed.No white flocs or foreign matter was found.The team was not able to confirm the reported issue.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on customer feedback, the team has concluded that the white flocs could be composed of plastic shavings coming from the own syringe and accumulated during the barrel transport process.The exact root cause is not able to be determined.
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Event Description
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It was reported that the bd discardit¿ ii 20 ml syringe experienced foreign matter in the fluid path.The following information was provided by the initial reporter: dispensing, white flocs are found in the syringe.
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Search Alerts/Recalls
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