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

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2018

Event Type  Injury  

Event Description

Information was received that following the sterilization of a smiths medical tracheostomy, the obturator was unable to be removed as it was stuck inside the tracheostomy.

Manufacturer Narrative

Patient information a): an identifier (b)(4) was updated.The patient was also reported as male.Product problem was updated to an adverse event- required intervention/serious injury due to the reporter noting in the source documentation noting the child receives a new tracheostomy (trach) every two weeks.Event date was updated to (b)(6) 2018.Information received noted the aware date was (b)(6) 2018.The aware date was updated from (b)(6) 2018 to (b)(6) 2018.

• Brand Name: TRACHEOSTOMY SILICONE BIVONA TUBES NEO/PED TTS
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL, ASD INC. MHYT; boundary road; kent, hythe ; UK
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8009862
• MDR Text Key: 125186892
• Report Number: 3012307300-2018-01925
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention