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

Model Number 670180

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Event Description

Information received a smiths medical tracheostomy|silicone - bivona tubes adult tts malfunctioned.After a week in use, a tear in the cuff was noted.No adverse patient events reported.

Event Description

Investigation completed and summarized in h 10.

Manufacturer Narrative

Investigation completed on a smiths tracheostomy|silicone - bivona tubes adult tts.Visually inspected from 12? -16? with normal lighting revealed big split and cut in cuff.Relevant documents which were reviewed and correct for testing and inspection activities.Pwi-10007254 rev.101 clean/position/adhesive cuff.Pwi-10007269 rev.100 symmetry and leak test method.Pwi-10015937 rev.100 spray of teflon and insert valve.Av-10006853 rev.101 leak testing and cuff symmetry visual aid.10018857-001 rev.100 ifu-adult tts cuff tracheostomy.Rmd-10001843 rev.100 pfmea for bivona tracheostomy tubes.The caused and theory and consideration were revealed as: bad assembly, not follow the instructions.? manufacturing defect from the molder.No corrective actions were taken.However, as part of containment, production personnel were notified by quality engineer on 10/nov/2020 as awareness of the defect reported by the customer.

• Brand Name: BIVONA
• Type of Device: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10482921
• MDR Text Key: 205306170
• Report Number: 3012307300-2020-08964
• 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
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: 670180
• Device Catalogue Number: 670180
• Device Lot Number: 3869829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1