MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60PFSS35
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that hairline fractures were noticed on the trach near the hub.There was a patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Two devices were returned for evaluation.The returned devices were visually inspected.The testing could duplicate the customer reported problem, rips were detected on eyelets.Root cause will be determined through run rate trending as applicable.No further actions.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: 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20032072
• Report Number: 3012307300-2024-07946
• Device Sequence Number: 6423776
• Product Code: JOH
• UDI-Device Identifier: 15021312516777
• UDI-Public: (01)15021312516777(17)280909(10)4424759
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: Lay User/Patient
• Device Catalogue Number: 60PFSS35
• Device Lot Number: 4424759
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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: 4 YR
• Patient Sex: Male
• Patient Weight: 16 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White