Model Number 1050044 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K111959.If additional information becomes available, a follow up report will be submitted.
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Event Description
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It was reported ampoule leakage occurred.The reporter indicated that when the package was opened, it was found that the glue inside the package is missing and the leaking liquid had solidified.The event occurred before use with no patient harm.
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Manufacturer Narrative
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Investigation: no samples or picture showing the defect have been received.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill b.Braun surgical requirements.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it.Please note that when no samples are received our analysis is very limited.We regret any inconvenience this issue may have caused and thank you for your collaboration.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.No corrective/preventive actions needed.
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Search Alerts/Recalls
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