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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINAL ANES/EPIDURAL CATH KIT: 19 GA. X; ANESTHESIA CONDUCTION KIT
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SPINAL ANES/EPIDURAL CATH KIT: 19 GA. X; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number ASK-05560-WH
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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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Brand Name
SPINAL ANES/EPIDURAL CATH KIT: 19 GA. X
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key10818256
MDR Text Key215578475
Report Number1036844-2020-00292
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASK-05560-WH
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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