MAUDE Adverse Event Report: SALTER LABS SALTER LABS; ADULT NASAL CANNULA WITH 4' 3-CHANNEL TUBE

Model Number	16SOFT-4-50
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Irritation/sores can be manifested by itching, redness, rash or in extreme cases, open sores.Salter lab's 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 cannulas is not changed out on a regular basis or as indicated on the packaging sores or irritations may result.
Event or Problem Description
Skin allergy (redness and sharp heating of the skin of the face) not relieved by antihistamines but with cortisone after 3 days - as soon as the glasses are put on, the tingling warning of the allergy starts again - by changing glasses no reappearance - no dietary, medication or cosmetic changes. .
Event or Problem Description
Skin allergy (redness and sharp heating of the skin of the face) not relieved by antihistamines but with cortisone after 3 days - as soon as the glasses are put on, the tingling warning of the allergy starts again - by changing glasses no reappearance - no dietary, medication or cosmetic changes. .
Additional Manufacturer Narrative
Irritation/sores can be manifested by itching, redness, rash or in extreme cases, open sores.Salter lab's 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 cannulas is not changed out on a regular basis or as indicated on the packaging sores or irritations may result.The complaint investigation was performed based on the content of the issue reported.Based on the complaint report description, the patient experienced skin allergy.There was no return product, photo image, or video provided to confirm the skin allergy issue.The complaint history was reviewed in grand avenue from the reported dates of january 31, 2022, through january 31, 2024, for part number 16soft-4-50 for failure mode "skin irritation/reaction", this is the second (2) complaint reported for part number 16soft-4-50.There were four (4) complaint reported for the same issue for part number 16soft-7-50 under (b)(4) during the same timeframe for failure mode "skin irritation/reaction".Based on rma-20017a rev 3, oxygen cannula, product risk analysis under the known and foreseeable hazards "patient exposed to skin irritant" under id r3 was identified.The potential cause(s) of hazard (hazardous situation) cannula material contains irritants are 7 = severity, 2 = likelihood of occurrence, rpn is <14; therefore, the risk level is acceptable.Based ref-20001-c1 rev 1 on table 1a the risk is low.The regulatory / compliance risk is low.Reviewed sop-20021-c1 and a health hazard evaluation does not need to be performed as the occurrence for the hazard situation is 2 - improbable with a severity - 7.We will continue to monitor trends during our periodic complaint review meetings.

• Brand Name: SALTER LABS
• Common Device Name: ADULT NASAL CANNULA WITH 4' 3-CHANNEL 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: 18822871
• Report Number: 3000219639-2024-00012
• Device Sequence Number: 19958334
• Product Code: CAT
• UDI-Device Identifier: 10607411915830
• UDI-Public: 10607411915830
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 16SOFT-4-50
• Device Catalogue Number: 16SOFT-4-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/01/2024
• 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 Sex: Unknown