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

Model Number	240 BLUE TRACHEOSTOMY TUBE HOLDER
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
"trach tube holder fastener broke off.".
Additional Manufacturer Narrative
On (b)(6) 2022 we received report # (b)(4) in an email from the fda.The incident was reported as "voluntary" on 7/19/2022.It was reported that "trach tube fastener tab broke off".We immediately contacted the initial reporter and asked if she could send back the affected 240 device and provide some additional information about the circumstances around the incident.She replied that she was not at work and would not be able to mail the device.She also stated that she has a photograph of the device that she could send us, so we asked her to send the photo for review which she did.The photograph shows that the hook tab itself broke on the outside of the sewing stitch, not the stitching holding it in place.We contacted her again and pointed out that it did not look like the device was used for very long or at all, and asked if it broke right out of the packaging or when she was putting it on her patient? she replied that it broke off while applying to her patient.The new fastener tab became stuck to the back of the tie.When she attempted to remove it, the tab broke off.We have reviewed the dhr for dale 240 lot 21m3661 which was mentioned in the report, with no evidence of any issues noted in the document review, and functional test data noted that the devices met all internal requirements for peel and shear testing.The lot, (b)(4) pieces, was produced from 12/8/2021 to 12/20/2021 and was shipped between 5/17/2022 and 6/1/2022 to 26 different customers with no other complaints recorded.It should be noted that the submitted voluntary report (b)(4) contained incorrect information, in the device manufacturer only information section, the initial reporter filled in that this was a serious injury, which is not the case.The device seemed to malfunction when being changed by the caregiver so there was no injury to the patient.It appears that in this case, the individual tab was pulled beyond the strength limit of the molded flange tab causing it to break.

• Brand Name: DALE TRACHEOSTOMY TUBE HOLDER
• Common Device Name: DALE 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; frankllin, MA 02038-3298 ; 5083164608
• MDR Report Key: 15334637
• Report Number: 1214422-2022-00010
• Device Sequence Number: 17874438
• Product Code: CBH
• UDI-Device Identifier: 00817612020667
• UDI-Public: 00817612020667
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A#S-P#N/A
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/08/2022

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 BLUE TRACHEOSTOMY TUBE HOLDER
• Device Catalogue Number: 240
• Device Lot Number: 21M3661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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 Sex: Prefer Not To Disclose