T CONNECTOR MX453

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-05-26 for T CONNECTOR MX453 manufactured by Medex, Inc..

Event Text Entries

[391709] The reporter stated that the tubing was separating from the female luer lock. No further info available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1526863-2005-00030
• MDR Report Key: 611673
• Report Source: 05
• Date Received: 2005-05-26
• Date of Report: 2005-04-27
• Date Mfgr Received: 2005-04-27
• Date Added to Maude: 2005-06-09
• 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: 0
• Manufacturer Contact: TERRI DAVIS
• Manufacturer Street: 6250 SHIER-RINGS ROAD
• Manufacturer City: DUBLIN OH 43016
• Manufacturer Country: US
• Manufacturer Postal: 43016
• Manufacturer Phone: 6147915542
• Manufacturer G1: MEDEX
• Manufacturer Street: 6250 SHIER-RINGS ROAD
• Manufacturer City: DUBLIN OH 43016
• Manufacturer Country: US
• Manufacturer Postal Code: 43016
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: T CONNECTOR
• Generic Name: T-CONNECTOR
• Product Code: FKB
• Date Received: 2005-05-26
• Model Number: NA
• Catalog Number: MX453
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 601468
• Manufacturer: MEDEX, INC.
• Manufacturer Address: 6250 SHIER RINGS RD. DUBLIN OH 40316 US
• Baseline Brand Name: T-CONNECTOR
• Baseline Generic Name: T-CONNECTOR
• Baseline Model No: NA
• Baseline Catalog No: MX453
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-05-26