Model Number 1150-7M103 |
Device Problems
Loss of or Failure to Bond (1068); Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Needle has been supplied bulk non sterile to a kit packager.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).Initial reporter´s narrative: tonight while slowly pulling the tuohy needle out it broke.Palstic part came right off in my hand.I wasn't pulling that hard.
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Event Description
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Irn# (b)(4).Initial reporter´s narrative: tonight while slowly pulling the tuohy needle out it broke.Plastic part came right off in my hand.I wasn't pulling that hard.
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Manufacturer Narrative
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Needle has been supplied bulk non sterile to a kit packager.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.Based on risk assessment and clinical assessment file is considered as closed.
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Search Alerts/Recalls
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