MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® PORTEX BIVONA FLEXTEND¿ TTS¿ PEDIATRIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 60PFSS40

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2018

Event Type  Injury  

Event Description

It was reported that a patient pulled at the ventilation tubing and the portex® portex bivona flextend¿ tts¿ pediatric tracheostomy tube snapped.There was no harm or injury caused due to quick responses of the patient's parents.An emergency tracheostomy tube change was performed.The patient very quickly recovered and returned to normal status.The patient is invasively ventilated 24/7 via the tracheostomy.

Manufacturer Narrative

During the visual inspection of the portex® portex bivona flextend¿ tts¿ pediatric tracheostomy tube, the following was detected: it was seen that shaft was separated from the connector and the wire was stretched, a wire exposed was found in the shaft, it was seen that the whole adhesive was attached to the connector.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.After a review of the different verifications that are performed during the manufacturing process to detect damage components, the most probable root cause is that damaged occurred after the product left the shm facility.

• Brand Name: PORTEX® PORTEX BIVONA FLEXTEND¿ TTS¿ PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7720527
• MDR Text Key: 115056398
• Report Number: 3012307300-2018-02816
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/2022
• Device Catalogue Number: 60PFSS40
• Device Lot Number: 3522831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• 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 Age: 29 MO