MAUDE Adverse Event Report: WESTMED LLC ADULT SOFT TIP CANNULA WITH 7' 85 SHORE GREEN TUBING

Model Number	0556
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable per medwatch report of burnt smell with cannula present and o2 flow.The patient was deceased 50 minutes prior to the event.
Event or Problem Description
Describe the event or problem: 50 minutes after pt.Expired, noted a a burnt smell in the hallway in aicu across the second station, the staff checked at the nearby rooms where the burnt smell was sensed.In aicu, in the head of the deceased patient, found a nasal cannula on the top frontal area and the prongs of the nasal cannula has a strand of burnt hair sucked into it, where the burnt smell was coming from.The o2 supply from the delivery meter where the cannula was attached was immediately turned off.No burnt wound was noted on the head upon inspection however noted 2 burnt markings/holes on the pillow case and plastic cover of the pillow.Pictures taken, nasal cannula and pillows with pillow case saved and contained in a plastic bag.Provider notified and assessed the event at bedside.1.O2 supply to the nasal cannula was turned off and the the nc device was contained in a specimen plastic bag and labelled.2.Assessed head and back of the body, no burnt wound noted.3.Provider notified who came and assessed the event.4.The pillowcase and pillow were contained in a plastic bag.5.The event was documented.What was the original intended procedure? : no procedure.Patient had expired prior to the event occurring.
Additional Manufacturer Narrative
Reportable per medwatch report of burnt smell with cannula present and o2 flow.The patient was deceased 50 minutes prior to the event.Photos were sent to medwatch but not airlife.No photos or returned product.Complaint not confirmed.For both dates of product being made on lot 429387 (6/12 & 8/01) there were no nc's, the sampling plans passed and there is no inventory of product of lot 429387 left.In document (b)(4), the causation of the odor was the burning of hair.Line r70 states "burns or inhalation of combustion fumes", which applies since the patient was unable to inhale, but would be if they were alive.This causation is stated "use of oxygen near an ignition source (surgical fire)".The ifu has specific instructions to indicate oxygen as a flammable material, oxygen being provided to the cannula at the facility.S=9, o=1, rpn=9, rc=1.Complaint not confirmed.However, likely root cause is an outside source of ignition.If the product were contaminated or defective in anyway it would still require ignition to cause burning.The dangers of this event are extreme, which is why this product is manufactured with flame resistant materials and the ifu has a warning based on oxygen/combustion.
Event or Problem Description
Describe the event or problem: 50 minutes after pt.Expired, noted a a burnt smell in the hallway in aicu across the second station, the staff checked at the nearby rooms where the burnt smell was sensed.In aicu, in the head of the deceased patient, found a nasal cannula on the top frontal area and the prongs of the nasal cannula has a strand of burnt hair sucked into it, where the burnt smell was coming from.The o2 supply from the delivery meter where the cannula was attached was immediately turned off.No burnt wound was noted on the head upon inspection however noted 2 burnt markings/holes on the pillow case and plastic cover of the pillow.Pictures taken, nasal cannula and pillows with pillow case saved and contained in a plastic bag.Provider notified and assessed the event at bedside.1.O2 supply to the nasal cannula was turned off and the nc device was contained in a specimen plastic bag and labelled.2.Assessed head and back of the body, no burnt wound noted.3.Provider notified who came and assessed the event.4.The pillowcase and pillow were contained in a plastic bag.5.The event was documented.What was the original intended procedure? : no procedure.Patient had expired prior to the event occurring.
Event or Problem Description
Describe the event or problem: 50 minutes after pt.Expired, noted a burnt smell in the hallway in aicu across the second station, the staff checked at the nearby rooms where the burnt smell was sensed.In aicu, in the head of the deceased patient, found a nasal cannula on the top frontal area and the prongs of the nasal cannula has a strand of burnt hair sucked into it, where the burnt smell was coming from.The o2 supply from the delivery meter where the cannula was attached was immediately turned off.No burnt wound was noted on the head upon inspection however noted 2 burnt markings/holes on the pillowcase and plastic cover of the pillow.Pictures taken, nasal cannula and pillows with pillowcase saved and contained in a plastic bag.Provider notified and assessed the event at bedside.1.O2 supply to the nasal cannula was turned off and the nc device was contained in a specimen plastic bag and labelled.2.Assessed head and back of the body, no burnt wound noted.3.Provider notified who came and assessed the event.4.The pillowcase and pillow were contained in a plastic bag.5.The event was documented.What was the original intended procedure? no procedure.Patient had expired prior to the event occurring.
Additional Manufacturer Narrative
Reportable per medwatch report of burnt smell with cannula present and o2 flow.The patient was deceased 50 minutes prior to the event.Photos were sent to medwatch but not airlife.No photos or returned product.Complaint not confirmed.For both dates of product being made on lot 429387 (6/12 & 8/01) there were no nc's, the sampling plans passed and there is no inventory of product of lot 429387 left.In document rma-20017f, the causation of the odor was the burning of hair.Line r70 states "burns or inhalation of combustion fumes", which applies since the patient was unable to inhale, but would be if they were alive.This causation is stated "use of oxygen near an ignition source (surgical fire)".The ifu has specific instructions to indicate oxygen as a flammable material, oxygen being provided to the cannula at the facility.S=9, o=1, rpn=9, rc=1.Complaint not confirmed.However, likely root cause is an outside source of ignition.If the product were contaminated or defective in anyway it would still require ignition to cause burning.The dangers of this event are extreme, which is why this product is manufactured with flame resistant materials and the ifu has a warning based on oxygen/combustion.**udi related data quality updates only**.

• Brand Name: ADULT SOFT TIP CANNULA WITH 7' 85 SHORE GREEN TUBING
• Common Device Name: ADULT SOFT TIP CANNULA WITH 7' 85 SHORE GREEN TUBING
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18068630
• Report Number: 2028807-2023-00030
• Device Sequence Number: 12704963
• Product Code: CAT
• UDI-Device Identifier: 00709078002960
• UDI-Public: (01)00709078002960(10)429387
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0556
• Device Catalogue Number: 0556
• Device Lot Number: 429387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 10/06/2023; 10/06/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/22/2023; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White