Model Number 121251-30A |
Device Problems
Loss of or Failure to Bond (1068); Fracture (1260)
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Patient Problems
Pain (1994); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/19/2018 |
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) distribution subsidiary pajunk medical produkte gmbh.Currently the data is poor and the device has not been returned/ 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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Irn# (b)(4).Summarizing translation of initial reporter´s narrative: cannula got loosened from hub.
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Manufacturer Narrative
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Event took place in germany and has been reported through german distribution subsidiary pajunk medical produkte gmbh.Based on risk management file and clinical evaluation report file is considered as closed.- attachment: [complaint report for 389-18.Pdf].
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Event Description
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Irn# 591_389-18.Summarizing translation of initial reporter´s narrative: cannula got loosened from hub.
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Search Alerts/Recalls
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