MAUDE Adverse Event Report: SALTER LABS SALTER LABS; TUBING, OXYGEN, 3-CHANNEL 25' (GREEN)

Model Number	2025G-25
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
"separated where the tubing meets the connector."the first occasion resulted in numbness in my extremities before i noticed the disconnection and could have been deadly had i gone to sleep without discovering the problem.".
Additional Manufacturer Narrative
The tubing disconnect interrupted delivery supplemental oxygen to patient.
Additional Manufacturer Narrative
The tubing disconnect interrupted delivery supplemental oxygen to patient.Complaint history reviewed.There has been 1 similar complaint in the previous 24 months for product group 12 - tubing/connector under defect code "bond joint separation/disconnection".Without rm, lot #, or pictures of complaint, root cause cannot be verified.Most likely root cause is little/no bonding agent present on tubing where separated from connector.Application of bonding agent is a manual process and variation of amount applied to tubing is inherit to the process.Defects are mitigated through inspections based on statistical techniques.Risk(rma-20017c): r36: oxygen delivery interrupted - tubing components not bonded together securely - s=6 o=1 rpn=6.Rpn < 25, therefore risk is acceptable.
Event or Problem Description
"separated where the tubing meets the connector.""the first occasion resulted in numbness in my extremities before i noticed the disconnection and could have been deadly had i gone to sleep without discovering the problem.".

• Brand Name: SALTER LABS
• Common Device Name: TUBING, OXYGEN, 3-CHANNEL 25' (GREEN)
• 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: 16919107
• Report Number: 3000219639-2023-00014
• Device Sequence Number: 6720142
• Product Code: BYX
• UDI-Device Identifier: 00607411200649
• UDI-Public: 00607411200649
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: Lay User/Patient
• Device Model Number: 2025G-25
• Device Catalogue Number: 2025G-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 05/12/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown