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

Model Number	IPN923947
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medwatch report 5118021.
Event or Problem Description
It was reported via medwatch that "the rn exerted higher than normal traction when removing the epidural catheter causing it to snap.Per discussion with the rn involved, the catheter fell out as she was removing the dressing tape.Anesthesiologist believes the tip of the epidural catheter remains in the patient; x-ray confirmed no radiopaque foreign body present".Additional information received states that "a ct scan was not done as the patient had already discharged.X-ray confirmed no radiopaque foreign object present.No medical intervention done, but the anesthesiologist did speak with the patient for possible retention of a foreign body".No report of patient harm or injury.
Event or Problem Description
It was reported via medwatch that "the rn exerted higher than normal traction when removing the epidural catheter causing it to snap.Per discussion with the rn involved, the catheter fell out as she was removing the dressing tape.Anesthesiologist believes the tip of the epidural catheter remains in the patient; x-ray confirmed no radiopaque foreign body present".Additional information received states that "a ct scan was not done as the patient had already discharged.X-ray confirmed no radiopaque foreign object present.No medical intervention done, but the anesthesiologist did speak with the patient for possible retention of a foreign body".No report of patient harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action was required at the time of the report.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17252638
• Report Number: 9680794-2023-00456
• Device Sequence Number: 4795824
• Product Code: BSO
• UDI-Device Identifier: 10801902207439
• UDI-Public: 10801902207439
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: IPN923947
• Device Catalogue Number: AK-05502
• Device Lot Number: 33F23D0021
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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: N/A.; N/A.
• Patient Sex: Unknown