MAUDE Adverse Event Report: SALTER LABS SALTER LABS; ADULT NASAL CANNULA WITH 7' 3-CHANNEL TUBE - 50/CS

Model Number	16SOFT-7-50
Health Effect - Clinical Codes	Rash (2033); Burning Sensation (2146)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable as the patient has burning in the noise and upper lip.Irritation/sores can be manifested by itching, redness, rash or in extreme cases, open sores.The salter respiratory care products are generally made from plastic/pvc, which has a good safety profile for irritation and sensitivity.A plastic product may cause irritation/sores for several reasons, including, the device has been contaminated with an external substance (e.G., mold release agent, lotions, medications) which cause irritation/sores, using device for too long (may become rough or bacterially contaminated), or individual patient-specific hypersensitivity.If the oxygen cannula is not changed out on a regular basis or as indicated on the packaging sores or irritations may result.
Event or Problem Description
Ose piece is colored and patient is getting a burning sensation and rash.Patient is getting a burning sensation on her nose and got a really bad rash on her nose and top lip.
Additional Manufacturer Narrative
Reportable as the patient has burning in the noise and upper lip.Irritation/sores can be manifested by itching, redness, rash or in extreme cases, open sores.The salter respiratory care products are generally made from plastic/pvc, which has a good safety profile for irritation and sensitivity.A plastic product may cause irritation/sores for several reasons, including, the device has been contaminated with an external substance (e.G., mold release agent, lotions, medications) which cause irritation/sores, using device for too long (may become rough or bacterially contaminated), or individual patient-specific hypersensitivity.If the oxygen cannula is not changed out on a regular basis or as indicated on the packaging sores or irritations may result (b)(4).Device has been contaminated with an external substance (e.G, mold release agent, lotions, medications) which cause irritation.Using device for too long (may become rough or bacterially contaminated).Individual patient-specific hypersensitivity.Biocompatibility testing, including irritation and sensitivity has been performed on the materials used in salter labs products.All tested materials demonstrate good biocompatibility.The devices are manufactured with non-latex materials.The historical complaint rate is low (normalized).Rma-20017a rev 2: r3 identifies a skin irritation (e.G.Skin rash) as an extreme (7/10) severity.Based on this severity rating and product trending this does not meet the threshold for carb review and no capa will be initiated.
Event or Problem Description
Ose piece is colored and patient is getting a burning sensation and rash.Patient is getting a burning sensation on her nose and got a really bad rash on her nose and top lip.

• Brand Name: SALTER LABS
• Common Device Name: ADULT NASAL CANNULA WITH 7' 3-CHANNEL TUBE - 50/CS
• 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: 14737112
• Report Number: 3000219639-2022-00030
• Device Sequence Number: 14049022
• Product Code: CAT
• UDI-Device Identifier: 10607411915779
• UDI-Public: 10607411915779
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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: 16SOFT-7-50
• Device Catalogue Number: 16SOFT-7-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 06/17/2022
• 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