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	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The eyeglass tube is coming loose or does not fit at the joint between the tube and the nasal part. .
Additional Manufacturer Narrative
The disconnection could prevent the patient from receiving oxygen and become hypoxic.
Additional Manufacturer Narrative
The disconnection could prevent the patient from receiving oxygen and become hypoxic.The complaint of " the eyeglass tube is coming loose or does not fit at the joint between the tube and the nasal part." regarding part 1053-7-50 was not confirmed.The root cause was not determined.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been no other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
The eyeglass tube is coming loose or does not fit at the joint between the tube and the nasal part. .

• 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: 18946341
• Report Number: 3000219639-2024-00029
• Device Sequence Number: 8052199
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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: 1053-7-50
• Device Catalogue Number: 1053-7-50
• Device Lot Number: 367714
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/20/2024
• 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