Model Number 1185-3E080 |
Device Problems
Nonstandard Device (1420); Failure to Prime (1492); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); No Flow (2991)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/20/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in the us and has been reported through us distributor.Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
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Event Description
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(b)(4).Customer claims they cannot inject through the needles.It seems as if there is some type of blockage in the cannula.Sometimes they only get a few drips pushed through, sometimes nothing will push through and other times there are no issues with the needles.A very random occurence.This was discovered during the flushing phase and prior to injecting the patient.Customer has requested product replacements.At least 20 needles involved.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.
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Event Description
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(b)(4).Reporter´s narrative: customer claims they cannot inject through the needles.It seems as if there is some type of blockage in the cannula.Sometimes they only get a few drips pushed through, sometimes nothing will push through and other times there are no issues with the needles.A very random occurence.This was discovered during the flushing phase and prior to injecting the patient.Customer has requested product replacements.At least 20 needles involved.
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Search Alerts/Recalls
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