MAUDE Adverse Event Report: DALE MEDICAL PRODUCTS, INC. DALE TRACHEOSTOMY TUBE HOLDER

Model Number	240
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
"adolescent patient with tracheostomy tube and mechanical ventilation.While doing trach care, velcro part of the trach.Holder / strap broke off completely from the soft part of the strap that encircles the neck.Staff member changed to a new holder and ensured it was secure.Thirty minutes later, the velcro part broke again, and holder was replaced again.No actual patient harm but potential for trach tube dislodgement.".
Additional Manufacturer Narrative
It was reported that on (b)(6) 2021 there was an adolescent patient with a tracheostomy tube and mechanical ventilation, and while doing trach care, the velcro part of the trach holder / strap broke off completely from the soft part of the strap that circles the neck.A staff member changed to a new holder and ensured it was secure.Thirty minutes later, the velcro part broke again, and the holder was replaced again.No patient harm was reported.On the same day, we received a second report of another issue of an adolescent patient with a tracheostomy tube and mechanical ventilation, but on 12/26/2021.We contacted the initial reporter to get additional information about both events and the devices: the initial reporter confirmed that both reports were relative to the same patient.The initial reporter confirmed that the facility did not retain any of the broken devices for manufacturer review and the lot numbers for the (b)(6) 2021.Event were unknown, but the lot number for the (b)(6) 2021.Event is 21h2318.The initial reporter could not confirm if the (velcro) tabs had broken or if they had come unsewn from the neck strap.The initial reporter confirmed that she did check with other departments at johns hopkins that uses the dale 240 device to see if there were any other issues noted and there were not.Without having defective or suspect devices to review or even the actual lot number associated with this event, dale medical cannot confirm a cause for the issue.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: DALE TRACHEOSTOMY TUBE HOLDER
• Common Device Name: TRACHEOSTOMY TUBE HOLDER
• Manufacturer (Section D): DALE MEDICAL PRODUCTS, INC.; 40 kenwood circle; suite 7; franklin MA 02038 3298
• Manufacturer (Section G): DALE MEDICAL PRODUCTS, INC.; 40 kenwood circle; suite 7; franklin MA 02038 3298
• Manufacturer Contact: raymond gruneberg ; 40 kenwood circle; suite 7; franklin, MA 02038-3298 ; 5083164608
• MDR Report Key: 14013346
• Report Number: 1214422-2022-00001
• Device Sequence Number: 11915402
• Product Code: CBH
• UDI-Device Identifier: 00817612020667
• UDI-Public: 00817612020667
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: LISTING ONLY
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/24/2022

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: 240
• Device Catalogue Number: 240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 21 KG