MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TTS PEDI FLEXTEND STRAIGHT NECK; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 67PFSS55

Device Problems Deflation Problem (1149); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  Injury  

Event Description

It was reported the device was observed to have a spontaneous leak either in the cuff or in the blocker line after three months of use.The event occurred while in use with a patient and there was a medical intervention required: repeated suction due to increased stimulus and leaking water.There was no patient harm reported.

Manufacturer Narrative

E1.Initial reporter phone#: (b)(6).Investigation summary: one used unit was received for investigation.It was identified that the sample had conditions of use, the cuff was slightly inflated.The sample was inflated with the use of a syringe to detect any problem in the inflation system, a leak was identified in the inflation line.The failure mode of ¿cuff deflation/leakage¿ was confirmed, however it was detected by the customer after 3 months of use in the patient.A capa was opened to address the root cause of cuffed products not inflating symmetrically, not maintaining inflation, and leaking.A device history record could not be completed as no lot number was received.

• Brand Name: BIVONA TTS PEDI FLEXTEND STRAIGHT NECK
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 60045 ; 2247062300
• MDR Report Key: 18989323
• MDR Text Key: 338738782
• Report Number: 9617604-2024-00263
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 67PFSS55
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male