MAUDE Adverse Event Report: SALTER LABS SALTER LABS; CANNULA, ADULT, HIGH FLOW, OXYGEN W/3-CHANNEL TUBE 7

Model Number	1600HF-7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The split tubing caused an interruption of therapy that could lead to hypoxia.
Event or Problem Description
An update from our clinical team on a home visit with a patient where the high flow cannula has split at the connection where the clear tubing feeds in the green section.Patient noticed when he felt the oxygen was escaping.No packaging to see which batch this was from.
Additional Manufacturer Narrative
The split tubing caused an interruption of therapy that could lead to hypoxia complaint history reviewed.There has been 1 similar complaint in the previous 24 months for 1600hf cannula.Background information reviewed.Pictures show tubing disconnection at the wye.Complaint confirmed.Most probable root cause is poor mek bond strength.Poor mek bond strength can be caused by several factors, including aging of the cannula, poor mek application during manufacturing, or extended use of the cannula.Risk(rma-20017a): r26: oxygen delivery interrupted - cannula components not bonded together securely - s=8 o=2 rpn=16.Rpn < 25, therefore risk is acceptable.
Event or Problem Description
An update from our clinical team on a home visit with a patient where the high flow cannula has split at the connection where the clear tubing feeds in the green section.Patient noticed when he felt the oxygen was escaping.No packaging to see which batch this was from.

• Brand Name: SALTER LABS
• Common Device Name: CANNULA, ADULT, HIGH FLOW, OXYGEN W/3-CHANNEL TUBE 7
• 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: 16965644
• Report Number: 3000219639-2023-00016
• Device Sequence Number: 5225064
• Product Code: CAT
• UDI-Device Identifier: 00607411101625
• UDI-Public: 00607411101625
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1600HF-7
• Device Catalogue Number: 1600HF-7
• Device Lot Number: 10210412,10210419,10210503,102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/19/2023
• 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