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

Model Number 2025G-25

Device Problem Disconnection (1171)

Patient Problem Numbness (2415)

Event Date 04/03/2023

Event Type  malfunction  

Event 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.".

Manufacturer Narrative

The tubing disconnect interrupted delivery supplemental oxygen to patient.

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 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
• Type of Device: 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
• MDR Text Key: 315457789
• Report Number: 3000219639-2023-00014
• Device Sequence Number: 1
• Product Code: BYX
• UDI-Device Identifier: 00607411200649
• UDI-Public: 00607411200649
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2025G-25
• Device Catalogue Number: 2025G-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other