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

Model Number	240
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 02/07/2022 we received report # (b)(4) from the noted facility.It was reported on (b)(6) 2022, that when changing trach ties, i went to tighten the ties and the white fastener ripped right off.It was noted that this happened during a trach care procedure.The submitted report, indicated a product problem, not adverse event.On 02/07/2022 we called the initial reporter and left a voice mail requesting a call back to dale medical to review the details of the issue.On 02/08/2022 we emailed the initial reporter and asked a series of questions about the noted issue: is there any chance the broken device is available for return, or is there a picture available? the narrative indicates when changing trach ties, the white fastener ripped right off; can you tell us if the white tab itself broke, or did the sewing stitch attaching the tab to the neckband break? i am assuming that the broken trach tie was the new one being put on, not the old one being taken off, correct? how often are the trach holders generally replaced for this patient? on 02/11/2022 we called the initial reporter again and spoke with her.She indicated that she forwarded our email with the questions to the reporting unit.On 02/16/2022, the initial reported emailed us and said that she is still waiting for a response from the reporting unit.On 03/02/2022, we emailed the initial reporter to see if there was any feedback from the reporting unit.Dale medical performed a complete review of the device history records (dhr) for dale 240 lot 21h2318 which was mentioned in the facility report, and performed functional testing on sample 240 devices from this lot number.No evidence of any issues was noted in the document review, and testing found that the devices meet all internal test requirements for peel and shear testing.Based on our document review and testing of samples from this production lot and without having actual defective devices to review, dale medical cannot confirm a cause for the issue.
Event or Problem Description
When changing trach ties, i went to tighten the ties and the white fastener ripped right off.

• Brand Name: DALE TRACHEOSTOMY TUBE HOLDER
• Common Device Name: TRACHESOTOMY 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: 14013581
• Report Number: 1214422-2022-00003
• Device Sequence Number: 4612914
• Product Code: CBH
• UDI-Device Identifier: 00817612020667
• UDI-Public: 00817612020667
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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 Expiration Date: 08/31/2026
• Device Model Number: 240
• Device Catalogue Number: 240
• Device Lot Number: 21H2318
• 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: 02/07/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Male