MAUDE Adverse Event Report: SALTER LABSNASAL CANNULA TUBING-ADULTOXYGEN TUBING

Event Date 06/06/2009

Event Type  Injury   Patient Outcome  Other

Event Description

Pt had reaction to oxygen tubing because allergy to corn starch and tubing contains corn starch per the pt allergies. There is not a warning on label of tubing to alert staff, pt to use caution with pts with corn allergies. Dose: 2 liters. Frequency: continuous. Route: nasal. Dates of use: continuous, 2009. Diagnosis: chronic hypoxia. Event abated after use stopped: yes.

• Brand Name: NASAL CANNULA TUBING-ADULT
• Type of Device: OXYGEN TUBING
• Manufacturer (Section F): SALTER LABS; 100 west sycamore rd; arvin CA
• Manufacturer (Section D): SALTER LABS; 100 west sycamore rd; arvin CA
• Device Event Key: 1557458
• MDR Report Key: 1514236
• Event Key: 1441225
• Report Number: MW5013122
• Device Sequence Number: 1
• Product Code: CAT
• Report Source: Voluntary
• Reporter Occupation: RISK MANAGER
• Type of Report: Initial
• Report Date: 10/19/2009

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/19/2009
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Device EXPIRATION Date: 01/01/2012
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?