LUXFER TC-3ALM139LUXFER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-10 for LUXFER TC-3ALM139LUXFER * manufactured by Luxfer Cylinder.

Event Text Entries

[21391346] Transfill tech was removing a just filled e-cylinder from the fill rack. While handling it, the valve exploded from the top of the cylinder and struck them in the abdomen. Pt was hospitalized overnight. No indication of life threatening or serious permanent injury. Cylinder and valve are scheduled for tests and examination to determine failure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1028674
• MDR Report Key: 468167
• Date Received: 2003-06-10
• Date of Event: 2003-05-08
• Date Added to Maude: 2003-06-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: LUXFER
• Generic Name: ALUM E-CYLINDER
• Product Code: CAW
• Date Received: 2003-06-10
• Model Number: TC-3ALM139LUXFER
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 457089
• Manufacturer: LUXFER CYLINDER
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: SHERWOOD
• Generic Name: CYLINDER TOGGLE VALUE
• Product Code: CBP
• Date Received: 2003-06-10
• Model Number: VALVE ID SHERWOOD 1702
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 457092
• Manufacturer: SHERWOOD VALVE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2003-06-10