MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY

Model Number 3.5MM

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Hypoventilation (1916)

Event Date 09/22/2020

Event Type  Injury  

Event Description

Information received a smiths medical tracheostomy|silicone - bivona tubes neo/ped flextend plus trach tubes had split at the flextend and in turn exposed the metal wire and allowed a twelve year old girl ventilation support to escape via this split in the tube.Reported has happened various occasions.Before use the tubes had been sterilized about 2-3 times using the steam sterilizer method.Also uses the disconnection wedge provided when disconnecting the trach from the vent tubing although the patient does connect herself.This incident required intervention of tracheotomy change out.

Manufacturer Narrative

Other, other text: h3: two pictures of a bivona tracheostomy tube were received for evaluation.One split was observed in the tube over the connector.No samples were received to perform inspection or testing.The reported issue was able to be confirmed.This issue could have been caused by damage to the surface of the tube during reprocessing or during the supplier process.

• Brand Name: BIVONA
• Type of Device: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10669943
• MDR Text Key: 211018186
• Report Number: 3012307300-2020-10292
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312516777
• UDI-Public: 15021312516777
• Combination Product (y/n): N
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3.5MM
• Device Catalogue Number: 60PFSS35
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 MO
• Patient Weight: 12