MAUDE Adverse Event Report: BIVONA CUSTOMIZED TRACHEOSTOMY TUBE; AIRWAY, ESOPHAGEAL (OBTURATOR)

Device Problems Disconnection (1171); Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Information was received indicating that during a routine change out of a smiths medical bivona customized tracheostomy tube, the metal introducer had become disconnected from the hub.It was thought that the technician did not put the introducers into the autoclave to set the adhesive.There were no reported adverse patient effects.

Manufacturer Narrative

Other, other text: one obturator was returned for analysis.The handle was noted to be detached from the obturator wire upon visual inspection.There was also adhesive visible on the obturator handle and inside the obturator handle hole.The device history record was unable to be reviewed as there was no part number or lot number provided.Based on the evidence, the complaint was confirmed.However, the root cause is unknown.Also, seeing that the complaint is specifically on the obturator itself, the product code was updated.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBE
• Type of Device: AIRWAY, ESOPHAGEAL (OBTURATOR)
• MDR Report Key: 10210352
• MDR Text Key: 196909373
• Report Number: 3012307300-2020-06371
• Device Sequence Number: 1
• Product Code: CAO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14 MO
• Patient Weight: 8