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

Catalog Number	67PFP60
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received indicating that the connector cannot be released from a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube.Subsequently, the tube changed out with no reported adverse patient effects.
Additional Manufacturer Narrative
Evaluation results: one photograph of the bivona tracheostomy tube was received.From the picture it was observed that the bivona product was connected to an unknown product.No damaged could be detected on the unit.No root cause could be determined since no sample was received to perform a thorough investigation and from the pictures received the defect is unclear.As a preventive action a production personnel was notified by the quality engineer on 06/may/2019 to make them aware of the defect reported by the customer.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.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8202396
• Report Number: 3012307300-2018-09047
• Device Sequence Number: 1710517
• Product Code: JOH
• UDI-Device Identifier: 10351688518538
• UDI-Public: 10351688518538
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: No Information
• Device Catalogue Number: 67PFP60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 06/05/2019
• 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