ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM PR-41541-BAS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-04 for ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM PR-41541-BAS manufactured by Arrow International Inc..

MAUDE Entry Details

• Report Number: 9680794-2019-00366
• MDR Report Key: 9156397
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-10-04
• Date of Report: 2019-09-11
• Date of Event: 2019-09-10
• Date Mfgr Received: 2019-10-16
• Device Manufacturer Date: 2019-05-07
• Date Added to Maude: 2019-10-04
• 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
• 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 INTERNATIONAL DE MEXICO S.A. DE C.V.
• Manufacturer Street: AVE. WASHINGTON 3701 COLONIA PANAMERICANA, CHIHUAHUA
• Manufacturer City: CHIHUAHUA 31200
• Manufacturer Country: MX
• Manufacturer Postal Code: 31200
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
• Generic Name: MIDLINE CATHETER
• Product Code: PND
• Date Received: 2019-10-04
• Returned To Mfg: 2019-10-08
• Catalog Number: PR-41541-BAS
• Lot Number: 13F19E0163
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ARROW INTERNATIONAL INC.
• Manufacturer Address: READING PA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-04