MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. BIVONA; TUBE TRACHEOSTOMY AND TUBE CUFF

Lot Number 3965911

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Manufacturer Narrative

Customer contact phone number: (b)(6).

Event Description

It was reported that the customer received a defective bivona tracheostomy tube.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

Other, other text: returned device was received for evaluation.During the evaluation of the device the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely and symmetrically.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: BIVONA
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11682235
• MDR Text Key: 245913196
• Report Number: 3012307300-2021-03224
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3965911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1