Model Number 001156-81 |
Device Problems
Contamination (1120); Device Contamination with Body Fluid (2317); Device Contamination With Biological Material (2908); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (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).User's narrative: presence of trace of brown stain at the tip of needle where it's introduced the mandrel.
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through (b)(4).As soon as further significant data will be available a follow up report will be sent in to the agency.Based on risk assessment and clinical evaluation file is considered as closed.
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Event Description
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(b)(4).User's narrative: presence of trace of brown stain at the tip of needle where it's introduced the mandrel.
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Search Alerts/Recalls
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