MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES NEO/PED; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2022

Event Type  Injury  

Event Description

It was reported that the child was being sucked from a 2.5 size intubation tube.When removing the blue connecting part from the tube itself, it broke off at the base with one side remaining inside the tube.The nurse called an emergency call and got extra hands quickly.0.5 cm was cut from the tube and i connected a new connector from the 2.0 size intubation tube to get the child back into the machine.The patient is doing well during the situation, because fortunately it lasted only a moment after being removed from the machine, but the situation could have been life-threatening.No injury reported.

Manufacturer Narrative

Udi and device serial number/lot number are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

Additional information received on 23-nov-2022 via email: no medical intervention was required; outcome of event--no problems; no tests/lad data needed.

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be performed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the reporting manufacturer will reopen this complaint for further investigation.

• Brand Name: BIVONA TUBES NEO/PED
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15845554
• MDR Text Key: 307689221
• Report Number: 3012307300-2022-27409
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention