MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; CSP ADULT CANNULA W/7' TUBING

Model Number R-0556-10,R-0556-5

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

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.This is reportable.The patient nose was caused to bleed.

Event Description

Nares are longer than normal. patient's nose has sores and experienced bleeding due to the long nares.

Manufacturer Narrative

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.This is reportable.The patient nose was caused to bleed.Complaint history reviewed.There have been 4 similar complaints in the previous 24 months.Inspection of product in inventory shows all product in inventory is out of specification.Ncmr-03164 opened to track further actions.Risk(rma-20017f): r48: low oxygen delivery - facepiece size does not fit patient, including nare length - s=8, o=1 rpn=8.Rpn <25.Therefore risk is acceptable.

Event Description

Nares are longer than normal. patient's nose has sores and experienced bleeding due to the long nares.

• Brand Name: WESTMED LLC
• Type of Device: CSP ADULT CANNULA W/7' 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: 17005511
• MDR Text Key: 315996854
• Report Number: 2028807-2023-00016
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: R-0556-10,R-0556-5
• Device Catalogue Number: R-0556-10,R-0556-5
• Device Lot Number: 368881,051022N09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other