MAUDE Adverse Event Report: SALTER LABS N/A; NASAL CANNULA (ADULT) SALTER STYLE WITH 7' (2.1 M) SUPPLY TUBE

Model Number	1600-7-50
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient developed lesions from the device and allergic reactions.
Event or Problem Description
When his oxygen was installed, he was provided with glasses which caused him an allergy, with itchy eczema-like lesions at the level of the tubing (under the chin, and in the neck).No change in cosmetic product habits that could explain an allergy.No misuse of the glasses.The patient saw the lesions disappear as soon as she changed her glasses model. .
Event or Problem Description
When his oxygen was installed, he was provided with glasses which caused him an allergy, with itchy eczema-like lesions at the level of the tubing (under the chin, and in the neck).No change in cosmetic product habits that could explain an allergy.No misuse of the glasses.The patient saw the lesions disappear as soon as she changed her glasses model. .
Additional Manufacturer Narrative
The patient developed lesions from the device and allergic reactions.There have been 2 similar complaints in the previous 24 months for 1600 series cannula under "skin irritation/reaction".No returned material, no pictures of defect/skin reaction.Complaint cannot be confirmed.Root cause: skin sensitization is a well-known risk and occurs most often when patients are first exposed to cannula or when using the cannula for a prolonged period of time.Cannulas may harden over time and cause irritation, that is why it is recommended to change cannula out every 14 days.Sensitivity to the pressure of the tubing can increase over time and can be mitigated by switching from 1600 to a 16soft style cannula or using products such as ez-wraps.Risk(rma-20017a): r1: patient skin contact with cannula - patient exposed to cannula repeatedly over long-term use - s=7 o=2 rpn=14.Rpn < 25, therefore risk is acceptable.
Additional Manufacturer Narrative
The patient developed lesions from the device and allergic reactions.There have been (b)(4) similar complaints in the previous 24 months for 1600 series cannula under "skin irritation/reaction".No returned material, no pictures of defect/skin reaction.Complaint cannot be confirmed.Root cause: skin sensitization is a well-known risk and occurs most often when patients are first exposed to cannula or when using the cannula for a prolonged period of time.Cannulas may harden over time and cause irritation, that is why it is recommended to change cannula out every 14 days.Sensitivity to the pressure of the tubing can increase over time and can be mitigated by switching from 1600 to a 16soft style cannula or using products such as ez-wraps.Risk(rma-20017a): r1: patient skin contact with cannula - patient exposed to cannula repeatedly over long-term use - s=7 o=2 rpn=14.Rpn < 25, therefore risk is acceptable.Udi related data quality updates only.
Event or Problem Description
When his oxygen was installed, he was provided with glasses which caused him an allergy, with itchy eczema-like lesions at the level of the tubing (under the chin, and in the neck).No change in cosmetic product habits that could explain an allergy.No misuse of the glasses.The patient saw the lesions disappear as soon as she changed her glasses model.

• Brand Name: N/A
• Common Device Name: NASAL CANNULA (ADULT) SALTER STYLE WITH 7' (2.1 M) SUPPLY TUBE
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17978299
• Report Number: 3000219639-2023-00028
• Device Sequence Number: 14066933
• Product Code: CAT
• UDI-Device Identifier: 10607411100250
• UDI-Public: (01)10607411100250
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Nurse Practitioner
• 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: 1600-7-50
• Device Catalogue Number: 1600-7-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 09/22/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/30/2023; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown