MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA PEDIATRIC FLEXTEND PLUS STRAIGHT NECK TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 67PFPS50

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 01/19/2024

Event Type  Injury  

Event Description

It was reported, that the tracheostomy tube became damaged after 147 days of use.With a hole forming at the junction of the outer cuff balloon.And the thin tube connecting it to the cuff's adjacent cuff.This resulted in leakage of the blocking solution.The customer had a replacement cannula, but expressed a desire to replace the defective product.There was patient involvement.And no patient harm/adverse event reported.

Manufacturer Narrative

E1: initial reporter phone#: (b)(6) 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.

Manufacturer Narrative

One device was received for investigation.It was identified that the sample has conditions of use, the inflation line has a hole at the joint of the tube and the pilot balloon.The reported failure mode was confirmed.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: BIVONA PEDIATRIC FLEXTEND PLUS STRAIGHT NECK TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18744143
• MDR Text Key: 335811849
• Report Number: 9617604-2024-00156
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 67PFPS50
• Device Lot Number: 4254218
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2024
• 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
• Treatment: BMV® CANNULA CLEANING POWDER
• Patient Outcome(s): Required Intervention
• Patient Sex: Female