MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM TTS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	CMZ3050N
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Skin Irritation (2076); Discomfort (2330)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event : per the reporter, three events have occurred since (b)(6) 2018 (first captured under (b)(6) 2018, the second and third listed as year 2019 with month unknown).Related to mfr numbers: 3012307300-2019-02092, 3012307300-2019-02121 (same patient with three same device issues).
Event or Problem Description
Information was received that three smiths medical bivona custom tts tracheostomy tubes were made for one patient.The reporter stated all three tubes have given the patient discomfort and pain while wearing them and that they "cause irritation inside the trachea.An old trach has to be put in while the trachea heals.When the trachea heals, they try another new trach and the same issue arises.This happened three times.The end of the tube has a bump that is thought to be causing the irritation".It was also noted the patient developed a tracheal erythema, but was able to recover once the tubes were changed out to a different custom smiths medical tracheostomy tube.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Three bivona custom tts tracheostomy tubes were returned for analysis.The products were visually inspected by unaided eye revealing bumps identified which are noted to be the cuff bands that secure the cuff to the shaft; no abnormality found.The three cuffs were compared noting slight variation among the three curves.All three devices measured within the manufacturing specification.Based on the evidence the allegation was not confirmed.However, the problem source was reported to be from manufacturing.It was suggested that the end user could not possibly tolerate the shaft curve.

• Brand Name: BIVONA CUSTOM TTS TRACHEOSTOMY TUBE
• 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: 8574517
• Report Number: 3012307300-2019-02122
• Device Sequence Number: 16204391
• Product Code: JOH
• UDI-Device Identifier: 15019517114270
• UDI-Public: 15019517114270
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: Lay User/Patient
• Device Expiration Date: 04/04/2023
• Device Model Number: CMZ3050N
• Device Catalogue Number: CMZ3050N
• Device Lot Number: DS015211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/29/2019
• 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
• Patient Age: 25 YR
• Patient Weight: 52