Model Number 928858 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is pending 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 syringe 0.3ml 31ga 8mm hub separated.Date of event: unknown.Samples: available.
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Event Description
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It was reported that 1 syringe 0.3ml 31ga 8mm hub separated.The following information was provided by the initial reporter : the consumer reported that the needle hub separated date of event: unknown samples: available.
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Manufacturer Narrative
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The following fields were updated due to additional information: d4: medical device lot #: 0098929.D4: medical device expiration date: 2025-04-30.H4: device manufacture date: 2020-04-07.D10: device available for eval yes.D10: returned to manufacturer on: 2021-07-13.H6: investigation summary customer returned (5) 31gx8mm, 0.3ml insulin syringes from lot# 0098929.Consumer reported that the needle hub separated.All 5 syringes were examined, and it was observed that each syringe had a needle hub/shield assembly properly attached removing each cannula shield did not result in hub separation.A review of the device history record was completed for batch # 0098929 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.A review of the device history record was completed for batch # 0006883 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure needle hub separation complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
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Search Alerts/Recalls
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