MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CUSTOM 4.0 TTS FLEXTEND NS + 1/EA; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FT19HN40NGF023N
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the silicone was peeling off from the hub.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.Visual inspection by the unaided eye and under normal plant lighting confirmed the silicone could be pulled away from the connecter.Using a dinolight, magnified pictures were taken after the silicone had been manipulated by several investigators (quality, molding, and assembly) and contributed to additional tearing / peeling of the silicone that is present in the pictures.It is believed that there may have been a short shot / void that occurred in the molding process that escaped detection during the in-process and final inspections.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: CUSTOM 4.0 TTS FLEXTEND NS + 1/EA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19932153
• Report Number: 1824231-2024-00071
• Device Sequence Number: 2760690
• Product Code: JOH
• UDI-Device Identifier: 15019517200812
• UDI-Public: (01)15019517200812(17)290514(10)GB020993
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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 Catalogue Number: FT19HN40NGF023N
• Device Lot Number: GB020993
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Sex: Female
• Patient Weight: 10 KG