Model Number 1150-6K091 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/09/2020 |
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)(6) distribution subsidiary pajunk medical produkte (b)(4).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).Tentative translation of initial reporter´s narrative: when the cannula was removed, the complete hub came off.The cannula tube had to be removed with a needle holder.
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Event Description
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Irn#: (b)(4).Tentative translation of initial reporter´s narrative: when the cannula was removed, the complete hub came off.The cannula tube had to be removed with a needle holder.
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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 assessment and clinical assessment case is considered as closed.
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Search Alerts/Recalls
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