Catalog Number ASK-05560-WH |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/26/2020 |
Event Type
Injury
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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 issue: i need to make each of you aware of an issue we had with an epidural catheter.Sadly, the provider who inserted the catheter does not know which product he used on this particular patient.Both are equally stocked in each room and we do not have a scanning system or sticker process to capture use for charging.When removing the epidural 4cm of the cath tip broke off and remained inside the patient.She had surgery last week for its removal.Part of our reporting to tjc requires we report the event to the manufacturer to see if you can give us any feedback or alert us if this has happened recently at another facility with your product.
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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 lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, e-17019-109a; rev.07, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance catheter more than 5 cm beyond the needle tip.Advancing catheter more than 5 cm increases the likelihood of catheter-related complications." the ifu warns the user, "the ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal." 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 provided for analysis.A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter 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.
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Event Description
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Reported issue: i need to make each of you aware of an issue we had with an epidural catheter.Sadly, the provider who inserted the catheter does not know which product he used on this particular patient.Both are equally stocked in each room and we do not have a scanning system or sticker process to capture use for charging.When removing the epidural 4cm of the cath tip broke off and remained inside the patient.She had surgery last week for its removal.Part of our reporting to tjc requires we report the event to the manufacturer to see if you can give us any feedback or alert us if this has happened recently at another facility with your product.
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Search Alerts/Recalls
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