Model Number 1150-7K103 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.In original condition the needle has been supplied in bulk, non sterile status to a kit packager.
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Event Description
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(b)(4).Initial reporter´s narrative: doctor placed the touhy needle and pulled on the hub of the stylet to remove it.The hub came off the end of the stylet, which remained in the needle.
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Manufacturer Narrative
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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.In original condition the needle has been supplied in bulk, non sterile status to a kit packager.Based on risk assessment and clinical evaluation report this file is considered as closed.
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Event Description
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Irn#: (b)(4).Initial reporter´s narrative: doctor placed the touhy needle and pulled on the hub of the stylet to remove it.The hub came off the end of the stylet, which remained in the needle.
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Search Alerts/Recalls
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