MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOS; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60PFS40
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that upon removal tracheostomy tubing from another manufacturer was stuck and unable to be disconnected from this tracheostomy.The provided wedge was used and was unable to disconnect the tubing.Due to this incident, this patient experienced discomfort.An emergency tracheostomy tube change was required.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
One used sample was returned for evaluation.The device was returned with an attached swivel connector.The investigator was able to separate the connector on the tube from the swivel connector easily.During examination the reported issue could not be confirmed.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures: this included review of basic assembly, manual cleaning, incoming inspection and inspection after assembly processes.The manufacturing facility also performed an in-process visual inspection of (b)(4) products that were in the assembly area: this inspection showed no molding issues (short shots, splits, voids or bubbling) with the products being assembled.The review of the manufacturing process determined that the production personnel performed the connector-to-tube operation correctly and the production personnel were performing inspection of the tube dimensions correctly.The reported issue could not be confirmed during testing.

• Brand Name: PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOS
• 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: 7007689
• Report Number: 3012307300-2017-02370
• Device Sequence Number: 13735856
• Product Code: JOH
• UDI-Device Identifier: 15021312005868
• UDI-Public: 15021312005868
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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: Nurse
• Device Catalogue Number: 60PFS40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRIOLOGY TUBING
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention