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

Model Number	IPN919609
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: the spinal needle was removed, and the epidural catheter was attempted to be threaded.It would not advance beyond the tip of the needle.After multiple efforts to thread the catheter the catheter gave a pop sensation, and then threaded.The catheter felt snug in the tuohy needle when the tuohy needle was removed.A close-up photo of the tip of the epidural needle was taken and there is a lip of metal that is at the tip of the needle orifice facing inward.This is where the catheter was catching on in our attempt to advance the catheter.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.Associated report 1036844-2023-00014.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer did provide a photo that appears to show a bent tip on an epidural needle.A device history record review was performed on the epidural catheter and epidural needle with no relevant findings.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 or Problem Description
Reported issue: the spinal needle was removed, and the epidural catheter was attempted to be threaded.It would not advance beyond the tip of the needle.After multiple efforts to thread the catheter the catheter gave a pop sensation, and then threaded.The catheter felt snug in the tuohy needle when the tuohy needle was removed.A close-up photo of the tip of the epidural needle was taken and there is a lip of metal that is at the tip of the needle orifice facing inward.This is where the catheter was catching on in our attempt to advance the catheter.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Common Device Name: 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: 16539052
• Report Number: 1036844-2023-00015
• Device Sequence Number: 17640638
• Product Code: BSO
• UDI-Device Identifier: 10801902189117
• UDI-Public: 10801902189117
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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 Expiration Date: 10/31/2023
• Device Model Number: IPN919609
• Device Catalogue Number: AK-05502
• Device Lot Number: 13F22K0547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown