Model Number 1185-3E080 |
Device Problems
Nonstandard Device (1420); Failure to Prime (1492); Product Quality Problem (1506); Defective Device (2588); 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 07/13/2016 |
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).Reporter´s narrative: could not push fluid through line.Could not even prime line.Might have 2, 3 samples of the defective needles.At least 15 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: could not push fluid through line.Could not even prime line.Might have 2, 3 samples of the defective needles.At least 15 needles involved.
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Search Alerts/Recalls
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