Model Number 121167-30A |
Device Problems
Bent (1059); Manufacturing, Packaging or Shipping Problem (2975); Device Handling Problem (3265)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in the (b)(6) and has been reported through (b)(4).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).Initial reporter´s narrative: on receipt the needles were found to be bent between hub and introducer making the use/control of the needle direction impossible, they were put aside and not used.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.(b)(4).
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Event Description
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Irn# (b)(4).Initial reporter´s narrative: on receipt the needles were found to be bent between hub and introducer making the use/control of the needle impossible, they were put aside and not used.
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Search Alerts/Recalls
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