MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ULTRAPERC PORTEX BLUE LINE ULTRA KIT; TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH

Model Number	100/591/070
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the balloon of tracheostomy tube from a smiths medical ultraperc portex blue line ultra kit did not inflate once inserted.Subsequently another tracheostomy tube was used.No adverse patient effects were reported.
Additional Manufacturer Narrative
Evaluation results: one portex tracheostomy tube was returned for investigation in used condition without its original packaging. the returned sample was visually inspected at a distance of 12" to 16" and normal conditions of illumination.The investigator noted that the inflation line was cut.An inflation test could not be performed as a result.A root cause could not be established.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: ULTRAPERC PORTEX BLUE LINE ULTRA KIT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9099996
• Report Number: 3012307300-2019-01674
• Device Sequence Number: 2402243
• Product Code: JOH
• UDI-Device Identifier: 15019315048289
• UDI-Public: 15019315048289
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K041348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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 Expiration Date: 06/05/2021
• Device Model Number: 100/591/070
• Device Catalogue Number: 100/591/070
• Device Lot Number: 3650419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 09/20/2019
• 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