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

Model Number	67PFPS45
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Possible lot numbers (d4): 3700959, 3708636.
Event or Problem 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.
Additional 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
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8591091
• Report Number: 3012307300-2019-02519
• Device Sequence Number: 2293410
• Product Code: JOH
• UDI-Device Identifier: 10351688518552
• UDI-Public: 10351688518552
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 67PFPS45
• Device Catalogue Number: 67PFPS45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 YR
• Patient Weight: 13