Model Number 324911 |
Device Problems
Component Missing (2306); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2023 |
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 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 veo¿ insulin syringes with bd ultra-fine¿ needle was damaged.The following information was provided by the initial reporter: syringe plunger deformed.
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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: 24-feb-2023.Investigation summary: the customer returned two 0.5ml 31ga syringes reporting that there was an issue with the syringes, one of the plungers was deformed and the second one was missing the needle.The syringes were visually inspected.Upon visual inspection, embecta was able to confirm that the needle hub separates from the barrel.Manufacturing (holdrege) will be notified of the observed issue.A review of the device history record was completed for batch# 2103775.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to duplicate or confirm the customer¿s indicated failure of needle hub separates from the barrel.A definitive root cause cannot be determined.
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Event Description
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It was reported that the bd veo¿ insulin syringes with bd ultra-fine¿ needle was damaged.The following information was provided by the initial reporter: syringe plunger deformed.
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Search Alerts/Recalls
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