MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® ULTRAPERC® SINGLE STAGE DILATOR TECHNIQUE KITS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/890/090CZ
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that a smiths medical portex® ultraperc® single stage dilator was found to be protruding 5mm from the end of the uniperc tracheostomy (trach) tube causing coughing and discomfort.There were no reported adverse effects.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Visual inspection of the device found the inner cannula to be protruding; the tube was noted to be deformed, confirming the reported customer complaint.The reported tube tip deformation was caused because tube was inserted too far onto the mandrel during the curving process, and was verified in production by simulation.

• Brand Name: PORTEX® ULTRAPERC® SINGLE STAGE DILATOR TECHNIQUE KITS
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7500867
• Report Number: 3012307300-2018-01472
• Device Sequence Number: 19136734
• Product Code: BTO
• UDI-Device Identifier: 15019315107184
• UDI-Public: 15019315107184
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Catalogue Number: 100/890/090CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1