Catalog Number EJ-05400-NRO |
Device Problem
Difficult to Advance (2920)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 01/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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Reported event: the user felt that the bevel of the cannula and stylet were not aligned; there was resistance and difficulty inserting the epidural needle in the patient.Therefore, the epidural needle was replaced with a new one.There was an accidental needle stick to the patient's spine but no serious injury occurred.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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Reported event: the user felt that the bevel of the cannula and stylet were not aligned; there was resistance and difficulty inserting the epidural needle in the patient.Therefore, the epidural needle was replaced with a new one.There was an accidental needle stick to the patient's spine but no serious injury occurred.
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Search Alerts/Recalls
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