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

Model Number	1601-7-50
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This could have been an interruption in therapy had they not been removed from the patient.
Event or Problem Description
It was observed that the low flow nasal cannula broke while being taken off the patient.The tubing seemed to have come loose from the part of the cannula that rests in the patient's nose.
Event or Problem Description
It was observed that the low flow nasal cannula broke while being taken off the patient.The tubing seemed to have come loose from the part of the cannula that rests in the patient's nose. .
Additional Manufacturer Narrative
This could have been an interruption in therapy had they not been removed from the patient.No images or returned inventory, complaint unconfirmed.The issue was stated as the low flow nasal cannula broke as it was being removed from the patient, the tubing slipped from the face piece.There was no inventory from lot 394908 for product 1601-7-50.There was evidence of scrap for all parts of the assembly present.During visual inspections there were more parts pulled, there were no deviations or nonconformities.In the last 24 months, there have been 6 related complaints with 1601-7-50 and 22 confirmed within the product family.Patient risk- in rma-20017a, for step r26, the issue is described as "oxygen delivery interrupted", with a causation "cannula components not bonded together securely", there was no indication during the dhr review that pull testing was missed, therefore s=8.O=2, rpn=16 (less than 25 risk is acceptable), rc=1.Root cause cannot be determined at this time.However, likely root cause is lack of bonding agent applied to the face piece during assembly.See (b)(6).

• Brand Name: SALTER LABS
• Common Device Name: CANNULA, INFANT, 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: 18773722
• Report Number: 3000219639-2024-00021
• Device Sequence Number: 15388293
• Product Code: CAT
• UDI-Device Identifier: 20607411100387
• UDI-Public: 20607411100387
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: 1601-7-50
• Device Catalogue Number: 1601-7-50
• Device Lot Number: 394908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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