MAUDE Adverse Event Report: SALTER LABS SALTER LABS; TUBING, OXYGEN, 3-CHANNEL 50' (GREEN) - 20/CS

Model Number	2050G-50-20
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable as patient was hospitalized after tripping over tubing.
Event or Problem Description
The tubing coils and caused a patient to fall.The end user stated he has changed his tubing multiple times and continues to have issues with it coiling.He orders through apria and vitality medical.The patient fell and ended up in the hospital because he tripped over the tubing.
Additional Manufacturer Narrative
Reportable as patient was hospitalized after tripping over tubing.A review of complaints submitted over the past 24 months for the product family "12-tubing/connector" and found four previous complaints.This is issue is not trending for this product or family of product as there is an overall downward trend.An inventory search was conducted for this part number and lot # and stock was no longer available in inventory.Dhrs were reviewed for the tubing extrusion operation as well as the finished packaging process.No nonconformances were noted and in process checks were performed and passed all success criteria.The tubing is extruded and automatically fed into an auto-coiling container.The process is controlled which minimizes damage to tubing material and lowers the risk of atypical behavior of the tubing material.The most likely cause for the coiling is improper usage or storage of the cannula leading to material coiling.(b)(4) rev 3: r77 identifies trippping from tubing causing a fall as a severe (8/10) severity.This complaint was reviewed at 5/26/2022 carb and was approved for no capa.
Event or Problem Description
The tubing coils and caused a patient to fall.The end user stated he has changed his tubing multiple times and continues to have issues with it coiling.He orders through apria and vitality medical.The patient fell and ended up in the hospital because he tripped over the tubing.

• Brand Name: SALTER LABS
• Common Device Name: TUBING, OXYGEN, 3-CHANNEL 50' (GREEN) - 20/CS
• 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: 14701685
• Report Number: 3000219639-2022-00027
• Device Sequence Number: 4743764
• Product Code: BYX
• UDI-Device Identifier: 10607411200639
• UDI-Public: 10607411200639
• Combination Product (Y/N): N
• 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): 06/15/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 2050G-50-20
• Device Catalogue Number: 2050G-50-20
• Device Lot Number: 21022B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 06/16/2022
• 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