Model Number 531157-31A |
Device Problems
Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Handling Problem (3265)
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Patient Problems
Pain (1994); No Known Impact Or Consequence To Patient (2692)
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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).Date of event unknown.Tentative summarizing translation from initial reporter´s narrative: unable to advance catheter through needle.Three kits affected.
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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).Date of event still unknown.Tentative summarizing translation from initial reporter's narrative: unable to advance catheter through needle.
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Search Alerts/Recalls
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