MAUDE Adverse Event Report: SALTER LABS SALTER LABS; ADULT NASAL CANNULA WITH 25', 3- CHANNEL TUBE

Model Number	16SOFT-HF-25
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was an interruption of therapy that could lead to hypoxia.
Event or Problem Description
Kinking is preventing flow of oxygen. patient claims this is a life threatening issue as they are not able to get adequate oxygen.
Event or Problem Description
Kinking is preventing flow of oxygen. patient claims this is a life threatening issue as they are not able to get adequate oxygen.
Additional Manufacturer Narrative
There was an interruption of therapy that could lead to hypoxia.Complaint history reviewed.There have been no similar complaints for 1600hf-25 cannula in the previous 24 months.More information sent via text message and phone call from customer.Customer receives product from medical supplier as well as purchasing from amazon.Lot# 354817 was bent/kinked in package.Purchased from amazon.Sunmed does not use amazon as a distributor and cannot control the quality of product during transit.Most likely root cause of defects is product mishandling during transit.Risk(rma-20017a): r97: low oxygen delivery - cannula material deteriorates resulting in leaks prior to first use - s=6 o=1 rpn=6.Rpn < 25.R100: low oxygen delivery - cannula tubing deteriorates resulting in tubing collapse prior to first use - s=8 o=1 rpn=8.Rpn < 25, therefore risk is acceptable.Product was purchased through an unapproved distributor (amazon), issue will not be brought to carb.

• Brand Name: SALTER LABS
• Common Device Name: ADULT NASAL CANNULA WITH 25', 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: 16919645
• Report Number: 3000219639-2023-00015
• Device Sequence Number: 6756650
• Product Code: CAT
• UDI-Device Identifier: 00607411915871
• UDI-Public: 00607411915871
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: Lay User/Patient
• Device Model Number: 16SOFT-HF-25
• Device Catalogue Number: 16SOFT-HF-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/15/2023
• 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