MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA FLEXTEND TTS PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 67PFPS45

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

Possible lot numbers (d4): 3700959, 3708636.

Event Description

Information was received that a smiths medical portex bivona flextend tts pediatric tracheostomy tube was placed in a patient after a routine tracheostomy (trach) tube change.When the tube was placed, it was reported that "the sheath over the obturator moved up and jammed so that the obturator was not able to be taken out".Subsequently, the trach had to be taken out and the old device was put back into the patient.There were no adverse patient effects.Information was received that a smiths medical portex bivona flextend tts pediatric tracheostomy tube was placed in a patient after a routine tracheostomy (trach) tube change.When the tube was placed, it was reported that "the sheath over the obturator moved up and jammed so that the obturator was not able to be taken out".Subsequently, the trach had to be taken out and the old device was put back into the patient.There were no adverse patient effects.

Manufacturer Narrative

Evaluation results: two photographs of bivona tracheostomy tubes were received for investigation.No damage could be detected in the obturators.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.No root cause could be determinated since the complaint was not confirmed.

• Brand Name: PORTEX BIVONA FLEXTEND TTS PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8591091
• MDR Text Key: 144422230
• Report Number: 3012307300-2019-02519
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 10351688518552
• UDI-Public: 10351688518552
• Combination Product (y/n): N
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 67PFPS45
• Device Catalogue Number: 67PFPS45
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Weight: 13