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

Model Number	ZZ19JN80ZSC098N
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient's cuff was tested before insertion and no leakage was noticed at the time.During filling in the evening, a leakage was noticed for the first time and water leaked into the trachea.This was noticed on (b)(6) 2020.Per the reporter, a tube change out was not completed at that time (this reporting decision was captured under the first related file, 3012307300-2020-01603).Then on (b)(6) 2020, the cuff of the same tracheostomy (trach) tube as before burst without any manipulation.At this point, an emergency trach change was done.Due to the patient being under ventilated and due to the reported leakage, the reporter stated the patient had to go to the emergency room.It was also noted that 12 ml of water escaped from the cuff and went into the patient.Furthermore, the reporter added that the patient was unable to use cough assist, so the health condition of the patient deteriorated.Additionally, the reporter stated an infusion therapy and further diagnostic measures had to be taken.No additional adverse patient effects were reported.

• Brand Name: BIVONA CUSTOM TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9771683
• Report Number: 3012307300-2020-01604
• Device Sequence Number: 19387242
• Product Code: JOH
• UDI-Device Identifier: 15019517209099
• UDI-Public: 15019517209099
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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?: Yes
• Operator of Device: No Information
• Device Model Number: ZZ19JN80ZSC098N
• Device Catalogue Number: ZZ19JN80ZSC098N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/28/2020
• 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