MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM; CATHETER, INTRAVASCULAR, THERA

Catalog Number CA-22703

Device Problems Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: defective guide wire, badly kinked.The reported defect was detected prior to patient use.No patient involvement reported.

Manufacturer Narrative

(b)(4).The sample was not returned; however, the customer did provide a photo of a severely bent and unraveled guide wire.The reported complaint of a damaged guide wire was confirmed by the customer photo.However, without the device to evaluation, complaint verification testing could not be performed.A device history record review was performed and no relevant findings were identified.The probable cause of this complaint could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: defective guide wire, badly kinked.The reported defect was detected prior to patient use.No patient involvement reported.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7573589
• MDR Text Key: 110359480
• Report Number: 3003737899-2018-00071
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: CA-22703
• Device Lot Number: 13F18A0523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2018
• 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