MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATHETERIZATION KIT; WIRE GUIDE CATHETER

Catalog Number	ASK-01218-HM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "'i have heard from two of the icu app's that the arrow arterial line kit has a bent arriving in the kit.This results in new product being added to the kit.' this has happened in more than 2 kits." there was no paitent involvement therefor no harm or injury.Associated mdr number include 9680794-2024-00242 and 9680794-2024-00141.
Event or Problem Description
It was reported "'i have heard from two of the icu app's that the arrow arterial line kit has a bent arriving in the kit.This results in new product being added to the kit.' this has happened in more than 2 kits." there was no paitent involvement therefor no harm or injury.Associated mdr number include 9680794-2024-00242 and 9680794-2024-00141.
Additional Manufacturer Narrative
Qn#(b)(4).Upon additional review of event information, it was determined that the malfunction was not reportable; thus , the initial mdr, submitted on 27-feb-2024, should be retracted.

• Brand Name: ARROW ARTERIAL CATHETERIZATION KIT
• Common Device Name: WIRE GUIDE 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18790560
• Report Number: 9680794-2024-00243
• Device Sequence Number: 20915996
• Product Code: DQX
• UDI-Device Identifier: 10801902217049
• UDI-Public: 10801902217049
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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 Catalogue Number: ASK-01218-HM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown