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

Model Number IPN919630

Device Problem Material Separation (1562)

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

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported event: yesterday we had an incident with an epidural catheter that broke an hour or so after placement.The issue was noted when the patient was not feeling relief from her epidural.Upon investigation, the epidural catheter was broken approximately two feet from the tip.The anesthesiologist repaired the tubing by cutting the end and securing a new blue cap to the end and reconnected to the infusion tubing through the epidural pump using aseptic technique.No harm to the patient occurred.The catheter was secured using tegaderm and it had been in use for 18 hours in a patient who was not ambulatory.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Reported event: yesterday we had an incident with an epidural catheter that broke an hour or so after placement.The issue was noted when the patient was not feeling relief from her epidural.Upon investigation, the epidural catheter was broken approximately two feet from the tip.The anesthesiologist repaired the tubing by cutting the end and securing a new blue cap to the end and reconnected to the infusion tubing through the epidural pump using aseptic technique.No harm to the patient occurred.The catheter was secured using tegaderm and it had been in use for 18 hours in a patient who was not ambulatory.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16261701
• MDR Text Key: 308550125
• Report Number: 1036844-2023-00007
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902189315
• UDI-Public: 10801902189315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN919630
• Device Catalogue Number: SJ-05501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2023
• 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: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Sex: Female