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

Catalog Number ASK-01218-HM

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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 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.

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
• Type of Device: 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18790560
• MDR Text Key: 336627845
• Report Number: 9680794-2024-00243
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.