Model Number IPN046313 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Headache (1880)
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Event Date 11/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(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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It was reported that the epidural set syringe not generally vacuum to identify epidural space.Plungers loose and falling off.The device was removed entirely and replaced with a different brand (b braun) successfully.There was no serious injury, complications, or delay caused to the patient.Only exacerbation of headache due to multiple attempts.
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Event Description
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It was reported that the epidural set syringe not generally vacuum to identify epidural space.Plungers loose and falling off.The device was removed entirely and replaced with a different brand (b braun) successfully.There was no serious injury, complications, or delay caused to the patient.Only exacerbation of headache due to multiple attempts.
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Manufacturer Narrative
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(b)(4).Visual inspection could not be performed as no sample was returned for analysis.The customer did provide a photo that appears to show a sealed epidural catheter kit.A dimensional or functional inspection could not be performed as no sample was returned for analysis.Additional testing could not be performed as no sample was returned for analysis.A device history record review was performed on the lor syringe with no relevant findings.A design history review was performed for part #kz-05501-002 as a part of this complaint investigation.There have been no material changes for this part during the last two years that could have led to this complaint.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.A complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, 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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