Catalog Number 329459 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd ultra-fine¿ insulin syringe's plunger was loose.The following information was provided by the initial reporter, translated from portuguese to english: broken/loose plunger (plastic part of the plunger has come loosened from the rubber part).
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Manufacturer Narrative
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H.3.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 ultra-fine¿ insulin syringe's plunger was loose.The following information was provided by the initial reporter, translated from portuguese to english: broken/loose plunger (plastic part of the plunger has come loosened from the rubber part).
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Manufacturer Narrative
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H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st 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.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 situational analysis (sa) is required at this time.
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Search Alerts/Recalls
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