CENTURION IV8595

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-08 for CENTURION IV8595 manufactured by Centurion Medical Products.

Event Text Entries

[96846729] Filing for initial report, investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10

[96846730] Leaking occurred at the connection of the iv catheter and the extension set.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004519921-2018-00001
• MDR Report Key: 7173077
• Date Received: 2018-01-08
• Date of Report: 2017-12-15
• Date Mfgr Received: 2017-12-15
• Device Manufacturer Date: 2017-08-29
• Date Added to Maude: 2018-01-08
• 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: 5175465400
• Manufacturer G1: TRI-STATE DE MEXICO, S. DE R.L. DE C.V.
• Manufacturer City: MEXICALI, BAJA CALIFORNIA 21397
• Manufacturer Country: MX
• Manufacturer Postal Code: 21397
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CENTURION
• Generic Name: IV START KIT
• Product Code: LRS
• Date Received: 2018-01-08
• Model Number: IV8595
• Lot Number: 2017082390
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CENTURION MEDICAL PRODUCTS
• Manufacturer Address: 100 CENTURION WAY WILLIAMSTON MI 48895 US 48895

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-01-08