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

Model Number IPN923947

Device Problem Difficult to Remove (1528)

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

Event Date 05/13/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medwatch report 5118021.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 318560998
• Report Number: 9680794-2023-00456
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902207439
• UDI-Public: 10801902207439
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.