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

Model Number 2050G-50-20

Device Problem Material Twisted/Bent (2981)

Patient Problem Fall (1848)

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

Reportable as patient was hospitalized after tripping over tubing.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 296779297
• Report Number: 3000219639-2022-00027
• Device Sequence Number: 1
• Product Code: BYX
• UDI-Device Identifier: 10607411200639
• UDI-Public: 10607411200639
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other