OXYGEN TUBING RCI 1827 1827

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-06 for OXYGEN TUBING RCI 1827 1827 manufactured by Rci Hudson.

Event Text Entries

[4826190] These seriously defective oxygen tubing products almost choked me to death by cutting off my oxygen supply while using my oxygen concentrator machine by knotting up and kinking up not allowing me to receive oxygen properly, in order to breath properly. This poorly made potentially deadly product should be recalled immediately. They are hudson rci ref 1827, softech adult nasal cannula, hudson rci oxygen tubing water trap and salter labs, ref 2021-21 supply line tubing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5038099
• MDR Report Key: 4080780
• Date Received: 2014-09-06
• Date of Report: 2014-09-06
• Date Added to Maude: 2014-09-11
• 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
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: OXYGEN TUBING
• Generic Name: SOFT ADULT NASAL CANNULA
• Product Code: CAT
• Date Received: 2014-09-06
• Model Number: RCI 1827
• Catalog Number: 1827
• Lot Number: 99434
• Operator: LAY USER/PATIENT
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RCI HUDSON

Device Sequence Number: 2

• Brand Name: SUPPLY LINE TUBING
• Generic Name: NASAL CANNULA
• Product Code: CAT
• Date Received: 2014-09-06
• Catalog Number: 2021-21
• Operator: LAY USER/PATIENT
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SALTER LABS

Device Sequence Number: 3

• Brand Name: OXYGEN TUBING WATER TRAP
• Generic Name: WATER TRAP
• Product Code: BYH
• Date Received: 2014-09-06
• Operator: LAY USER/PATIENT
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: RCI HUDSON

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Other	2014-09-06