Model Number IPN047800 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/03/2022 |
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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Writer noticed epidural catheter was disconnected while repositioning patient from side to side.Patient's dermatome levels were t5.Part of the catheter that is connected to patient writer locked with sterile syringe.Tape was intact over patient's back, no migration of catheter.Dr.Inserted new epidural catheter and patient was comfortable in a few minutes after insertion, fetal heart rate and baseline was the same, normal tracing.Maybe manufacturer should suggest placing tape over it and also what kind of tape should be applied.There is no warning (or suggestions from manufacturer) on the package that we need to use tape over these parts.
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Event Description
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Writer noticed epidural catheter was disconnected while repositioning patient from side to side.Patient's dermatome levels were t5.Part of the catheter that is connected to patient writer locked with sterile syringe.Tape was intact over patient's back, no migration of catheter.Dr inserted new epidural catheter and patient was comfortable in a few minutes after insertion, fetal heart rate and baseline was the same, normal tracing.Maybe manufacturer should suggest placing tape over it and also what kind of tape should be applied.There is no warning ( or suggestions from manufacturer ) on the package that we need to use tape over these parts.
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Manufacturer Narrative
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(b)(4).A device history review could not be performed on the epidural catheter as according to the bill of material (bom) for reported kit as-05500-1, an epidural catheter is not packaged with the reported kit.A device history record review was performed on the snaplock assembly with no relevant findings.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.Complaint verification testing could not be performed as no sample was returned for analysis.A device history review could not be performed on the epidural catheter as according to the bill of material (bom) for reported kit ou-05500-nron, an epidural catheter is not packaged with the reported kit.A device history record review was performed on the snaplock assembly with no evidence to indicate a manufacturing related issue.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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