Catalog Number EJ-05400-NRO |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).The device has not been returned for investigation.
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Event Description
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The user was unable to insert the catheter into the epidural needle smoothly because of resistance.Therefore, a new kit was used instead.
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Event Description
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The user was unable to insert the catheter into the epidural needle smoothly because of resistance.Therefore, a new kit was used instead.
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Manufacturer Narrative
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Qn# (b)(4).A lot number was not provided.A device history record review was performed based upon a potential lot number.A device history record review was performed on the epidural catheter and needle with no relevant findings.A design history review was performed for part # jz-05500-004n and kz-005400-030 as a part of this complaint investigation.There have been no material changes for these parts during the last two years that could have led to this complaint.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A lot number was not provided.A device history record review was performed based upon a potential lot number.A device history record review was performed on the epidural catheter and needle with no relevant findings.The potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.
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Search Alerts/Recalls
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