CENTURION INTROFLEX ECVC1915

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-07 for CENTURION INTROFLEX ECVC1915 manufactured by Centurion Medical Products.

Event Text Entries

[54075017] Device not returned.
Patient Sequence No: 1, Text Type: N, H10

[54075018] Introducer side port tube separated from the hub.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1038445-2016-00003
• MDR Report Key: 5932727
• Report Source: USER FACILITY
• Date Received: 2016-09-07
• Date of Report: 2016-09-07
• Date of Event: 2016-08-08
• Date Mfgr Received: 2016-08-02
• Date Added to Maude: 2016-09-07
• 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: MR. MATTHEW PRICE
• Manufacturer Street: 100 CENTURION WAY
• Manufacturer City: WILLIAMSTON MI 48895
• Manufacturer Country: US
• Manufacturer Postal: 48895
• Manufacturer Phone: 5175451135
• Manufacturer G1: CENTURION MEDICAL PRODUCTS
• Manufacturer Street: 3310 S MAIN ST.
• Manufacturer City: SALISBURY NC 28147
• Manufacturer Country: US
• Manufacturer Postal Code: 28147
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CENTURION INTROFLEX
• Generic Name: INTRAVASCULAR CATHETER, PRODUCT CODE: OES
• Product Code: OES
• Date Received: 2016-09-07
• Model Number: ECVC1915
• Operator: PHYSICIAN
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CENTURION MEDICAL PRODUCTS
• Manufacturer Address: 3310 S MAIN ST. SALISBURY NC 28147 US 28147

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2016-09-07