ARROW THORACENTESIS KIT AK-01000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-10-21 for ARROW THORACENTESIS KIT AK-01000 manufactured by Arrow International Inc..

MAUDE Entry Details

• Report Number: 9680794-2019-00400
• MDR Report Key: 9213898
• Report Source: HEALTH PROFESSIONAL,OTHER,USE
• Date Received: 2019-10-21
• Date of Report: 2019-10-09
• Date of Event: 2019-09-10
• Date Mfgr Received: 2019-11-12
• Device Manufacturer Date: 2019-06-11
• Date Added to Maude: 2019-10-21
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KATHARINE TARPLEY
• Manufacturer Street: 3015 CARRINGTON MILL BLVD
• Manufacturer City: MORRISVILLE NC 27560
• Manufacturer Country: US
• Manufacturer Postal: 27560
• Manufacturer Phone: 9194334854
• Manufacturer G1: ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
• Manufacturer Street: AVE. WASHINGTON 3701, EDIFICIO 4 COLONIA COMPLEJO INDUSTRIAL, LAS AMERICAS
• Manufacturer City: CHIHUAHUA 31114
• Manufacturer Country: MX
• Manufacturer Postal Code: 31114
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ARROW THORACENTESIS KIT
• Generic Name: CATHETER AND TIP SUCTION
• Product Code: JOL
• Date Received: 2019-10-21
• Catalog Number: AK-01000
• Lot Number: 13F19F0260
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ARROW INTERNATIONAL INC.
• Manufacturer Address: CHELMSFORD MA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-21