STELLANT CT SYRINGE KIT 86698188 SDS-CTP-SPK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-23 for STELLANT CT SYRINGE KIT 86698188 SDS-CTP-SPK manufactured by Bayer Medical Care Inc..

MAUDE Entry Details

• Report Number: 2520313-2020-00014
• MDR Report Key: 9868353
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-23
• Date of Report: 2020-04-01
• Date of Event: 2020-03-09
• Date Mfgr Received: 2020-03-09
• Device Manufacturer Date: 2020-01-30
• Date Added to Maude: 2020-03-23
• 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: DIANE ECKERT
• Manufacturer Street: 1 BAYER DRIVE
• Manufacturer City: INDIANOLA, PA PA 15051
• Manufacturer Country: US
• Manufacturer Postal: 15051
• Manufacturer Phone: 7249408677
• Manufacturer G1: BAYER MEDICAL CARE INC.
• Manufacturer Street: 1 BAYER DRIVE
• Manufacturer City: INDIANOLA, PA PA 15051
• Manufacturer Country: US
• Manufacturer Postal Code: 15051
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STELLANT CT SYRINGE KIT
• Generic Name: ANGIOGRAPHIC SYRINGE KIT
• Product Code: DXT
• Date Received: 2020-03-23
• Returned To Mfg: 2020-03-16
• Model Number: 86698188
• Catalog Number: SDS-CTP-SPK
• Lot Number: 8576343
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAYER MEDICAL CARE INC.
• Manufacturer Address: 1 BAYER DRIVE INDIANOLA PA 15051 US 15051

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-23