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

Model Number 670180

Device Problems Mechanical Problem (1384); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  Injury  

Event Description

Information was received indicating that a smiths medical tracheostomy|silicone - bivona tube adult tts was inserted and failed with ruptured cuff on the top.The reporter indicated that, the customer looked down the patient's trachea and found nothing sharp i.E.Cartilage that may have caused the rupture.Subsequently, the customer put 15 mls of water into a new size 7 bivona and it looked ok, inserted it, inflated the cuff with 10 mls of water then pulled out 10 mls 5 minutes after, confirming it was not being damaged on the way down.No patient consequences were reported.

Manufacturer Narrative

Other, other text: device evaluation: two smiths medical tracheostomy|silicone - bivona tube adult tts were returned for analysis in used condition without their original packaging.Visual inspection showed a big split in the cuff.Based on evidence and investigation, the complaint allegation was confirmed.One possible, but unconfirmed, problem source was listed as damage occurring after the product left smiths medical facilities since all cuff devices are 100% leak tested.

• Brand Name: BIVONA
• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10612879
• MDR Text Key: 209365513
• Report Number: 3012307300-2020-10005
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006070
• UDI-Public: 15021312006070
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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
• Device Model Number: 670180
• Device Catalogue Number: 670180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 03/28/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR