MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	526070
Medical Device Problem Codes	Accessory Incompatible (1004); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Related to mfrs (same patient, multiple cannula issues): 3012307300-2019-02854, 3012307300-2019-02852, 3012307300-2019-03577, 3012307300-2019-03578, 3012307300-2019-03579, 3012307300-2019-03581, 3012307300-2019-03582, 3012307300-2019-03583, 3012307300-2019-03584, 3012307300-2019-03585, 3012307300-2019-03586, 3012307300-2019-03587, 3012307300-2019-03588.Reporter stated they are a retired pediatric tracheostomy and ventilator nurse specialist.
Event or Problem Description
Information was received that a smiths medical portex tracheostomy replacement inner cannula would not latch into place immediately upon use.It was noted that the patient's daughter is a certified pediatric nurse and "she helped her out" at the time of the event.The reporter also stated the patient's tracheostomy tube "is changed monthly at doctor's order.We did not have to change it due to the cannula not snapping.The cannula was changed twice a day to decrease risk of infections and to maintain patency of the airway".Four routine tube change outs were completed since the start of the event to present time (july).The daughter reported they had the same problem of the cannulas not snapping even with a new tube.Subsequently, due to the reporter noting the patient had run low on a supply of cannulas, some cannulas had to be cleaned, boiled, and re-used.There were no adverse patient effects as a result of the event.

• Brand Name: PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA
• 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: 8809289
• Report Number: 3012307300-2019-03580
• Device Sequence Number: 326739
• Product Code: BTO
• UDI-Device Identifier: 10351688041135
• UDI-Public: 10351688041135
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K903730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: No Information
• Device Expiration Date: 01/17/2024
• Device Model Number: 526070
• Device Catalogue Number: 526070
• Device Lot Number: 3754297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1