MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA ADULT 8.0 MM UNCUFFED; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60A180
Medical Device Problem Codes	Defective Component (2292); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned to date.Device evaluation: a picture was submitted for investigation.Review of the provided picture showed a tear inside the eyelet.This type of defect is usually the result of the use of a trach holder that contains velcro.Without the benefit of sample, the claim of a manufacturing defect could not be confirmed.Visual and functional testing could not be performed.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.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that ¿the patient's nurse wanted to change his cannula with the one sent recently.She realized that the new one was defective.The attachments of the cannula are torn apart.The nurse put the cannula aside and warned us.A shipment of a new canula was organized with the store¿.The event occurred at the patient¿s home.There was patient involvement, without consequences but which caused or could have compromised the patient¿s safety.

• Brand Name: BIVONA ADULT 8.0 MM UNCUFFED
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 9124 polk ln, suite 101; olive branch MS 38654
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18972394
• Report Number: 3008818980-2024-00009
• Device Sequence Number: 14961273
• Product Code: JOH
• UDI-Device Identifier: 15021312005578
• UDI-Public: (01)15021312005578(17)271220(10)4354807
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K913859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

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: 60A180
• Device Lot Number: 4354807
• 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: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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: 59 YR
• Patient Sex: Male