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

Model Number IPN911814

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event 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.

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 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
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• MDR Report Key: 12313293
• MDR Text Key: 266221781
• Report Number: 1036844-2021-00149
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902140767
• UDI-Public: 10801902140767
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: IPN911814
• Device Catalogue Number: ASK-05400-BW1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 09/23/2021
• 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 Number: 1