MAUDE Adverse Event Report: SALTER LABS LLC SALTER LABS LLC; ADULT NASAL CANNULA WITH 4' 3-CHANNEL TUBE

Model Number	16SOFT-4-50
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	12/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable as patient had a decrease in oxygen, but was able to replace with new cannula.
Event or Problem Description
The canula came off at the connection while patient was traveling.
Additional Manufacturer Narrative
Reportable as patient had a decrease in oxygen, but was able to replace with new cannula.Complaint history reviewed.There have been 11 similar complaints in previous 24 months for 16soft products.Overall cpm is trending downward for product group 9-o2 cannula.Without returned material, root cause cannot be verified.However based on background information cannula tubing was most likely tugged or pulled while user was traveling, causing either bonding agent or tubing to deteriorate, which caused the tubing to separate.Disconnection is more likely to happen as the cannula ages.Users are recommended to not use cannula for longer than 14 days.Risk (rma-20017a): r22: low oxygen delivery - patient rip, breaks or damages tubing from pulling on cannula - s=8 o=2, rpn=16.Rpn < 25, therefore risk is acceptable.
Event or Problem Description
The canula came off at the connection while patient was traveling.

• Brand Name: SALTER LABS LLC
• Common Device Name: ADULT NASAL CANNULA WITH 4' 3-CHANNEL TUBE
• Manufacturer (Section D): SALTER LABS LLC; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS LLC; 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: 16070724
• Report Number: 3000219639-2022-00044
• Device Sequence Number: 6262984
• Product Code: CAT
• UDI-Device Identifier: 10607411915830
• UDI-Public: 10607411915830
• 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): 12/29/2022

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: 16SOFT-4-50
• Device Catalogue Number: 16SFT-4-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown