MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN911814
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
We had an issue with the kit below.Upon removal the catheter sheared at the 14 cm mark and was retained in the patient.We do not have the original packaging so do not have lot number.We are in the process of doing internal investigation but wanted to let you know as well.The distal tip of the catheter was retained and patient discharged.Remainder of the catheter is in house at danbury with their risk management team and they will not release it per hospital policy.Awaiting response from end user on technique.
Additional 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.Visual inspection could not be performed as no sample was returned by the customer for investigation.The customer did provide photos that appear to show a stretched epidural catheter (reference files pic1-tc# (b)(4)).A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned 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 relevant findings.The customer did provide photos that appear to show a stretched epidural catheter.However, without the actual sample, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.
Event or Problem Description
We had an issue with the kit below.Upon removal the catheter sheared at the 14 cm mark and was retained in the patient.We do not have the original packaging so do not have lot number.We are in the process of doing internal investigation but wanted to let you know as well.The distal tip of the catheter was retained and patient discharged.Remainder of the catheter is in house at (b)(4) with their risk management team and they will not release it per hospital policy.Awaiting response from end user on technique.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• MDR Report Key: 12313293
• Report Number: 1036844-2021-00149
• Device Sequence Number: 3181004
• Product Code: BSO
• UDI-Device Identifier: 10801902140767
• UDI-Public: 10801902140767
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN911814
• Device Catalogue Number: ASK-05400-BW1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1