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

Model Number ZZ19JN80ZSC098N

Device Problems Burst Container or Vessel (1074); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

Event Type  Injury  

Event 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
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary, in
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9771683
• MDR Text Key: 181653519
• Report Number: 3012307300-2020-01604
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517209099
• UDI-Public: 15019517209099
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ZZ19JN80ZSC098N
• Device Catalogue Number: ZZ19JN80ZSC098N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention