MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC STIMUCATH SFTY KIT: 19G CTH, 17GX9CM NDL; ANESTHESIA CONDUCTION KIT

Model Number IPN923940

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Other remarks: n/a; corrected data: n/a.

Event Description

It was reported that while in use on a patient, when "the [operator] went to remove the inner guidewire, the blue end fell off.They were able to get the wire out, but the catheter unraveled and kinked towards the tip.They replaced the catheter with another and the same thing happened".No patient harm or injury.The patient status is reported as "fine".

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 and 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.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that while in use on a patient, when "the [operator] went to remove the inner guidewire, the blue end fell off.They were able to get the wire out, but the catheter unraveled and kinked towards the tip.They replaced the catheter with another and the same thing happened".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: STIMUCATH SFTY KIT: 19G CTH, 17GX9CM NDL
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16713574
• MDR Text Key: 313036973
• Report Number: 9680794-2023-00301
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 10801902207361
• UDI-Public: 10801902207361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121403
• 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: 03/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN923940
• Device Catalogue Number: AB-05060-PKS
• Device Lot Number: 13F23A0886
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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