MAUDE Adverse Event Report: SALTER LABS N/A; NASAL CANNULA (INFANT) SALTER STYLE WITH 7' (2.1 M) SUPPLY TUBE

Model Number	1601-7-50
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is a potential for aspiration or swallowing of parts.
Event or Problem Description
Oxygen nasal prong leads broke from main port.
Additional Manufacturer Narrative
There is a potential for aspiration or swallowing of parts.There have been 3 previous complaints for 1601 cannula in the previous 24 months under associated production failure code "bond joint separation/disconnection." there is no returned material, or pictures provided of defective product.Complaint cannot be confirmed.Without returned material, or pictures of defective product root cause cannot be confirmed.Most likely root cause is patient pulled on tubing which separated the tubing from the connector, or not enough bonding agent was applied during assembly.Risk(rma-20017a): r22: low oxygen delivery - patient rips, breaks, damages tubing from pulling on cannula - s=8 o=2 rpn=16.Added to "escalation to capa" spreadsheet 11/28/2023.
Event or Problem Description
Oxygen nasal prong leads broke from main port.
Additional Manufacturer Narrative
There is a potential for aspiration or swallowing of parts.There have been 3 previous complaints for 1601 cannula in the previous 24 months under associated production failure code "bond joint separation/disconnection." there is no returned material, or pictures provided of defective product.Complaint cannot be confirmed.Without returned material, or pictures of defective product root cause cannot be confirmed.Most likely root cause is patient pulled on tubing which separated the tubing from the connector, or not enough bonding agent was applied during assembly.Risk(b)(4): r22: low oxygen delivery - patient rips, breaks, damages tubing from pulling on cannula - s=8 o=2 rpn=16.Added to "escalation to capa" spreadsheet 11/28/2023.**udi related data quality updates only**.
Event or Problem Description
Oxygen nasal prong leads broke from main port.

• Brand Name: N/A
• Common Device Name: NASAL CANNULA (INFANT) SALTER STYLE WITH 7' (2.1 M) SUPPLY 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: 17962051
• Report Number: 3000219639-2023-00033
• Device Sequence Number: 6800054
• Product Code: CAT
• UDI-Device Identifier: 20607411100387
• UDI-Public: (01)20607411100387
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 07/23/2024

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: Health Professional
• Device Model Number: 1601-7-50
• Device Catalogue Number: 1601-7-50
• Device Lot Number: UNKNOWN
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 09/18/2023; 09/18/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/30/2023; 07/23/2024
• 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