Catalog Number 326638 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone# : unknown.Initial reporter zip code : unknown.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 1 bd syringe 0.3ml 30ga 8mm hub separated from the device.The following information was provided by the initial reporter : the customer reported that when removing the shield the needle with the shield was separated from the barrel.
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Event Description
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It was reported that 1 bd syringe 0.3ml 30ga 8mm hub separated from the device.The following information was provided by the initial reporter : the customer reported that when removing the shield the needle with the shield was separated from the barrel.
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Manufacturer Narrative
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H6: investigation summary: no physical samples were received; the investigation was performed based on the photo provided.This is the 3rd related complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.The complaint could not be confirmed hence the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situation analysis (sa) is required at this time.
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Search Alerts/Recalls
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