Catalog Number 328468 |
Device Problems
Failure to Deliver (2338); Free or Unrestricted Flow (2945)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.Investigation summary : exec summary - no samples (including photos) were returned therefore bd was not able to duplicate or confirm the customer¿s indicated failure and the root cause is undetermined.A review of the complaint lot history check was performed and this is the 1st related complaint for (leakage and plunger difficult to operate) and the 2nd related complaint for difficult or unable to operate (not drawing) on this lot #.No non-conformances were raised in association with this type of event for this lot concluding all inspections were performed as per the applicable operations and met qc specifications.Capa/sa - based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.Dhr review - a lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.
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Event Description
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It was reported that 3 bd insulin syringes with the bd ultra fine¿needles were unable to aspirate.The following information was provided by the initial reporter : it was reported by the consumer being unable to draw medication from the vial and the insulin leaked from the syringe. date of event : unknown.Samples : not available.
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Search Alerts/Recalls
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