Catalog Number 328322 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 7 bd syringe 0.3ml 30ga 8mm hubs separated from the device.The following information was provided by the initial reporter : the clinic employee reported that when removing the orange protective cover the needle gets stuck in the cover making it impossible to use.
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Event Description
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It was reported that 7 bd syringe 0.3ml 30ga 8mm hubs separated from the device.The following information was provided by the initial reporter : the clinic employee reported that when removing the orange protective cover the needle gets stuck in the cover making it impossible to use.
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Manufacturer Narrative
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H6: investigation summary.No samples were returned therefore the investigation was performed based on the photos provided.Three photos were provided.The customer reported when removing the orange protective cover the needle gets stuck in the cover making it impossible to use.All three photos were examined, and it was observed that the needle hub/shield assembly was detached from the syringe.No damage was observed on the barrel tip.A review of the device history record was completed for batch # 0189401 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure based on the photos received.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.Capa pr1630423 has been opened to address this issue.H3 other text: see h10.
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Search Alerts/Recalls
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