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

Model Number	1053-7-50
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Nasal prongs come off & possibility of loss of o2 during use.
Additional Manufacturer Narrative
Reportable as there was an interruption of oxygen delivery.
Additional Manufacturer Narrative
Reportable as there was an interruption of oxygen delivery.Complaint history reviewed.There have been 2 similar complaints in the previous 24 months for 1053 cannula.Trend data shows an overall decrease in cpm and 12 month cpm for product group 9-o2 cannula.Without returned material, pictures of defective material, or lot# given, complaint cannot be confirmed.Most likely root cause of defect is not enough mek applied to tubing during assembly.Qa-23-184 was generated for this issue.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
Nasal prongs come off & possibility of loss of o2 during use.

• Brand Name: SALTER LABS
• Common Device Name: CANNULA, ADULT CONVENTIONAL, 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: 17512117
• Report Number: 3000219639-2023-00022
• Device Sequence Number: 12149879
• Product Code: CAT
• UDI-Device Identifier: 10607411101110
• UDI-Public: 10607411101110
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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: Health Professional
• Device Model Number: 1053-7-50
• Device Catalogue Number: 1053-7-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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