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

Model Number 16SOFT-HF-25

Device Problem Material Twisted/Bent (2981)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/13/2023

Event Type  Injury  

Manufacturer Narrative

There was an interruption of therapy that could lead to hypoxia.

Event 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 Description

Kinking is preventing flow of oxygen. patient claims this is a life threatening issue as they are not able to get adequate oxygen.

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
• Type of Device: 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
• MDR Text Key: 315098635
• Report Number: 3000219639-2023-00015
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 00607411915871
• UDI-Public: 00607411915871
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/13/2023
• 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